Medtronic recalls specific Passive Biopsy Needle Kits with UDI numbers 00643169030121 and 00643169702943 due to potential needle depth stop issues that could delay surgery. Affected units include certain lot numbers.
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
Medtronic is recalling specific Passive Biopsy Needle Kits that may not securely tighten, potentially delaying surgery. This recall affects medical professionals using these kits during procedures.
The biopsy needle depth stop may not tighten securely when the needle is used, which could lead to delays in surgical procedures. This is a manufacturing issue that affects the kit's functionality.
Medical professionals using the recalled Passive Biopsy Needle Kits during surgery are most at risk. The recall applies to specific units with listed UDI and lot numbers.
Check for UDI numbers 00643169030121 or 00643169702943 on the kit. Also look for lot numbers including 66503918A, 066513519A, and others listed in the recall notice.
Verify the kit's Unique Device Identifier (UDI) matches the recalled numbers: 00643169030121 or 00643169702943.
Check if the kit's lot number is among the listed numbers: 66503918A, 066513519A, 066529218A, and others.
The biopsy needle depth stop may not tighten securely when used, which could delay surgery due to a manufacturing issue.
Check for UDI numbers 00643169030121 or 00643169702943 and lot numbers listed in the recall notice, such as 66503918A or 066513519A.
The recall does not require immediate stop use; affected kits should be checked against the listed UDI and lot numbers.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0657-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0657-2020 from Medtronic. 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.
