Oscor, Inc. Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.
Brand
Oscor, Inc.
Lot Codes / Batch Numbers
02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
Products Sold
02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
Oscor, Inc. is recalling Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 057 due to The O-rings are over tolerance making it hard to connect the leads to the pacemaker.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
Recommended Action
Per FDA guidance
On January 24, 08, Oscor sent out a letter to doctors/ customers with the subject line of "Re: Market Withdrawal of Permanent Pacing Leads due to the lead connector insertion difficulty," stating they experienced some difficulties with the insertion of pacing lead connectors into the pacemaker headers. They asked that customers review the inventory list and remove all products, whose serial numbers match the serial numbers on the list and have not been implanted. Also, customers should call Oscor customer service for a Return Goods Product number and return the product back to the firm for replacement.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026