Datascope recalls TRANS-RAY IAB catheters due to risk of introducer dilator fracture during insertion, potentially causing arterial damage or embolization. 10 complaints including 3 serious events and 1 death reported.
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Datascope is recalling TRANS-RAY IAB catheters and accessories because the introducer dilator may fracture during insertion, risking damage to major blood vessels or causing life-threatening embolism. This recall follows 10 complaints including 3 serious adverse events and 1 patient death.
During catheter insertion, the introducer dilator can fracture at the hub, leaving the broken piece inside the sheath. This may damage the femoral artery, descending aorta, or cause embolization (traveling blood clots). It can also delay critical treatment or require emergency surgery.
Healthcare professionals using these catheters for counter-pulsation therapy in the aorta are affected. Patients undergoing this procedure are at risk if they have the recalled devices.
Check for the product names: TRANS-RAY IAB, TRANS-RAY PLUS IAB, or PACKAGED INSERTION KITS. Look for part numbers D684-00-0545-01 to D884-00-0019-26 or UDI codes 10607567107656 to 10607567111810.
Discontinue use of the recalled catheters and accessories immediately to prevent potential injury.
The introducer dilator may fracture during insertion, risking damage to major blood vessels or causing embolization, as reported in 10 complaints including 3 serious adverse events and 1 patient death.
TRANS-RAY IAB (7FR. 34cc and 40cc), TRANS-RAY PLUS (7.5Fr. 35cc and 40cc), and their associated insertion kits with part numbers D684-00-0545-01 to D884-00-0019-26.
Check the product labels for part numbers D684-00-0545-01 to D884-00-0019-26 or Unique Device Identifiers (UDIs) 10607567107656 to 10607567111810.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2218-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2218-2023 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
