Every recall we track for Datascope Corporation — 59 in all — plus the complaints and injury reports the public filed about them.
Datascope recalls Insertion Kits for SENSATION PLUS 8F catheters with undersized dilators that may cause injury during use. Affected units have specific lot numbers.
Datascope recalls Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters with undersized dilator. Affected units have specific lot numbers; contact for details.
Datascope recalls specific lots of MEGA 8Fr 50cc Intra-Aortic Balloon Catheters with undersized dilators that could cause complications during medical procedures.
Datascope recalls LINEAR 7.5Fr 40cc IAB with Accessories (Model 0684-00-0480-02) due to incorrect labeling that may delay critical therapy for hemodynamically unstable patients.
Datascope recalls Sensation 7Fr 34cc IAB kits with potential endotoxin contamination. Affected kits have specific part numbers and lot numbers. Consumers should contact Datascope for details.
Datascope recalls specific models of Intra-Aortic Ballon Catheters (IABs) due to potential endotoxin contamination. Affected kits include P/Ns 0684-00-0480-01 and others with listed lot numbers. Consumers should check their kit details and contact Datascope for guidance.
Datascope recalls Sensation 7Fr 40cc IAB kits with potential endotoxin contamination. Affected kits have specific part numbers and lot numbers. Consumers should contact Datascope for details.
Datascope recalls specific Intra-Aortic Balloon Catheter kits (Japan) due to potential endotoxin contamination. Affected kits have lot numbers listed; users should contact Datascope for details.
Datascope recalls Sensation Plus 7.5 Fr 40cc IAB kits with potential endotoxin contamination. Affected kits include specific model numbers and lot numbers. Consumers should contact Datascope for details.
Datascope recalls specific YAMATO PLUS-R 7.5Fr 30cc IAB kits (Japan) due to potential endotoxin contamination. Affected kits have listed lot numbers. Contact Datascope for details.
Datascope recalls specific 7.5Fr 40cc IAB kits (P/Ns 0684-00-0295-01 to 0684-00-0295-10) due to potential endotoxin contamination. Affected kits include certain lot numbers for cardiac and heart failure procedures.
Datascope recalls specific Trans-Ray 7Fr 34cc IAB kits (Japan) due to potential endotoxin contamination. Affected kits have listed lot numbers. Users should contact Datascope for details.
Datascope recalls specific YAMATO PLUS-R 7.5Fr 40cc IAB kits (Japan) due to potential endotoxin contamination. Affected kits have listed lot numbers. Contact Datascope for details.
Datascope recalls specific IAB catheters due to potential endotoxin contamination. Affected models include P/N 0684-00-0294-01 and variants. Consumers should check product details and contact Datascope for guidance.
Datascope recalls YAMATO PLUS-R 7.5Fr 35cc IAB kits (Japan) due to potential endotoxin contamination. Affected kits have specific lot numbers. Consumers should contact Datascope for details.
Datascope recalls specific 7.5Fr 25cc IAB kits due to potential endotoxin contamination. Affected kits include model numbers 0684-00-0478-01 and variants. Consumers should check lot numbers for affected units.
Datascope recalls Sensation Plus 8Fr 50cc IAB kits with potential endotoxin contamination. Affected kits include specific part numbers and lot numbers. Consumers should contact Datascope for details.
Datascope recalls specific models of Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. Affected kits include P/Ns 0684-00-0296-01 and others. Consumers should check their kit lot numbers for affected units.
Datascope recalls Japan-sold TRANS-RAY PLUS 7.5Fr 35cc IAB kits with potential endotoxin contamination. Affected kits have specific lot numbers. Users should contact Datascope for details.
Datascope recalls specific Trans-Ray 7Fr 40cc IAB catheters (Japan) due to potential endotoxin contamination. Affected kits have listed lot numbers; users should contact Datascope for details.
Datascope recalls specific models of Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. Affected kits include Linear 7.5Fr 34cc IAB Kit with certain lot numbers. Consumers should check their kit's product number and lot number for recall.
Datascope Corporation recalls specific lots of Maquet Reinforced Introducer Sets due to potential for compromised sterility if pouches are breached. Affected units have part number 068400040305 and specific lot codes.
Datascope Corporation recalls specific Maquet Reinforced Introducer Sets (part number 0684 00 0403 06) due to potential sterility compromise in breached pouches of certain lots. Affected units may pose infection risks if used improperly.
Datascope Corporation recalls specific lots of Maquet Reinforced Introducer Sets due to potential for compromised sterility in breached pouches. Affected units may pose infection risks if used improperly.
Datascope recalls Sensation Plus 7.5Fr 40cc Intra-Aortic Balloon Catheters with expired label due to reversed manufacture and expiry dates. Affected units may be used incorrectly.
Datascope recalls Mega 8FR 50cc intra-aortic balloon catheters due to missing contraindications in instructions. This could lead to unsafe use during counterpulsation therapy. Affected units include model 0684 00 0296 01U and 0684 00 0296 02U.
Datascope recalls Mega 7.5FR 40cc intra-aortic balloon catheters due to missing contraindications in instructions. This could lead to unsafe use during heart therapy. Affected units include model 0684 00 0295 01U and 0684 00 0295 02U.
Datascope recalls Mega 7.5FR 30cc Intra-Aortic Balloon Catheters due to missing contraindications in instructions. This may lead to unsafe use during counterpulsation therapy.
Datascope recalls BEQ-T 25501 3/8" Better Bladder Pack for potential air entry into ECMO circuits, risking blood flow drops. Affected units have Catalog No. 709000370.
Datascope recalls neonatal ECMO tubing kits with potential air entry risk causing blood flow drops. Affected units have specific catalog numbers and lots. Contact for remedy.
Datascope recalls Small Patient ECC Pack BEQ-TOP 22301 (Catalog No. 701049513) due to potential air entry causing blood flow drops in ECMO circuits.
Datascope recalls BEQ-TOP 33500 3/8" ECC PACK (Catalog No. 701053752) due to potential air entry causing ECMO circuit blood flow drops. Affected units have Lot 3000056255.
Datascope recalls BEQ-TOP 50903 Custom ECC Pack-Pedriatric tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific catalog numbers and lots.
Datascope recalls BEQ-TOP 8504 1/4X1/4 Pack tubing kits with catalog number 701066949R02 due to potential air entry causing blood flow drops in ECMO circuits. Affected units sold with lot 3000060844.
Datascope recalls BEQ-TOP 40700 HUNTINGTON tubing kits due to potential air entry causing ECMO blood flow drops. Affected units have catalog number 701062899.
Datascope recalls BEQ-TOP 24202 Adult ECMO bladders with potential air entry causing blood flow drops. Affected units have specific catalog and lot numbers. Stop using immediately.
Datascope recalls BEQ-TOP 25500 ECC 3/8 with Custom Tubing Kit (Catalog 701052461) due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific lot numbers.
Datascope recalls BEQ-T 9410 Lurie Chldns Small 1/4 Custom Tubing Kit (Catalog No. 709000430) due to potential air entry causing blood flow drops in ECMO circuits.
Datascope recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits with catalog number 701050253 due to potential air entry causing blood flow drops in ECMO circuits.
Datascope recalls BEQ-TOP 41201 ECC 3/8 PUMP PAC with custom tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific catalog numbers and lots.
Datascope recalls BO-TOP 20705 Small Patient 1/4 tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific catalog and lot numbers.
Datascope recalls NICU ECC Pack BEQ-TOP 39202 custom tubing kits due to potential air entry into ECMO circuits, risking blood flow drops. Affected units have Catalog No. 701067313R01 and Lot 3000061508.
Datascope recalls BEQ-TOP 49101 Childrens Large ECC Pack with custom tubing kits due to potential air entry causing blood flow drops in ECMO circuits.
Datascope recalls BEQ-T 25502 Better Bladder kits with potential air entry causing ECMO blood flow drops. Affected units sold with Catalog No. 709000434.
Datascope recalls BEQ-TOP 38900 ECC Pack with custom tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have catalog number 701056368.
Datascope recalls BEQ-TOP 22701 tubing kits for potential air entry into ECMO circuits, risking blood flow drops. Affected units have specific catalog numbers and lots.
Datascope recalls BEQ-TOP 5210 ECC Set respiratory tubing kits due to potential air entry causing ECMO circuit blood flow drops. Affected units have specific catalog numbers and lots.
Datascope recalls BO-TOP 20700 Small Patient 3/8 Custom Tubing Kit (Catalog 701050966) due to potential air entry in ECMO circuits causing blood flow drops.
Datascope recalls ECC Small Respiratory BEQ-TOP 5210 Custom Tubing Kit (Catalog No. 701055604) due to potential air entry causing blood flow drops in ECMO circuits.
Datascope recalls BO-TOP 13901 Rapid Response Custom Tubing Kit (Catalog 701054874) due to potential air entry causing blood flow drops in ECMO circuits.
Datascope recalls Adult ECC Pack BEQ-TOP 22300 (Catalog No. 701049504) due to potential air entry causing blood flow drops in ECMO circuits. Affected units include specific lots.
Datascope recalls BEQ-TOP 33700 ECC 3/8" Custom Tubing Packs with Bioline Coating (Catalog No. 701053845) due to potential air entry into ECMO circuits, risking blood flow drops. Affected units have specific lot numbers.
Datascope recalls BEQ-TOP 22301 Custom Tubing Kit (Catalog 701049513) due to potential air entry causing ECMO blood flow drops. Affected units sold with Lot 3000060036.
Datascope recalls BEQ-TOP 27610 ECC Pack 3/8 Custom Tubing Kits (Catalog 701065622) due to potential air entry causing blood flow drops in ECMO circuits. Affected units include specific lots.
Datascope recalls BEQ-TOP 22300 Custom Tubing Kit (Catalog 701049504) due to potential air entry causing ECMO blood flow drops. Affected units include specific lots.
Datascope recalls BEQ-TOP 22702 ECC W/HMOD 30000 (Catalog 701051179) due to potential air entry in ECMO circuits causing blood flow drops. Affected units have specific lot numbers.
