Datascope recalls specific lots of MEGA 8Fr 50cc Intra-Aortic Balloon Catheters with undersized dilators that could cause complications during medical procedures.
Certain lots containing undersized dilator.
Datascope is recalling certain lots of MEGA 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators that may cause complications during medical procedures. This recall affects healthcare professionals and patients using these catheters for critical treatments.
The catheters contain undersized dilators that may not properly expand during medical procedures, potentially causing complications like tissue damage or improper function. This issue arises from manufacturing inconsistencies in the dilator size.
Healthcare professionals and patients using the recalled catheters for medical procedures are affected. Those with the specific lot numbers listed in the recall are at risk of complications.
Check the catheter's code information for the lot numbers: 10607567109619, 10607567107301, or the finished goods part numbers listed in the recall notice.
Review the catheter's code information for the specific lot numbers or finished goods part numbers listed in the recall.
The catheters contain undersized dilators that may not expand properly during medical procedures, potentially causing complications.
Affected lots include 10607567109619, 10607567107301, and the corresponding finished goods part numbers listed in the recall notice.
The recall does not require immediate discontinuation; healthcare professionals should check the product details to confirm if their catheter is affected.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1685-2022 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1685-2022 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.
