Permanent Pacing Lead (Catalog #: 03332, 03334, 03337… recallZ-2333-2008 · Oscor, Inc. · initiated Jan 29, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oscor, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2333-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 29, 2008
- Posted by the FDA
- Sep 24, 2008
- Recalling firm
- Oscor, Inc.
- Product code
- DTB
- FDA submissions
- K010787, K040569, K041809, K872971
- Distribution
- Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
Other devices under the same FDA submission
2 devices cleared under K010787, K040569, K041809, K872971 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Lead Adaptor BIS/BIS-40Oscor Inc. · pacemaker lead Adaptor14 reports
- Lead Adaptor BIS/BIS-17Oscor Inc. · pacemaker lead Adaptor2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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