VV-Plug 667145-302Recalls & reported problems
Oscor Inc. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672008291), received between May 25, 2021 and May 25, 2021 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT LEADS WERE EXPLANTED DUE TO INFECTION. THERE WAS NO ISSUE WITH VV-PLUG REPORTED AND VV-PLUG REMAINS ACTIVELY IMPLANTED. THERE WAS SURGICAL INTERVENTION REPORTED TO EXPLANT THE LEAD. NO ADDITIONAL INFORMATION AVAILABLE. NO OTHER SERIOUS INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 11880821 ↗
Other pacemaker lead Adaptor devices
- Introducer Kit for Impella® 0052-3006Oscor Inc. · pacemaker lead Adaptor4 recalls223 deaths1,184 reports
- NA 5867-3MMedtronic, Inc. · pacemaker lead Adaptor25 reports
- Introducer Kit for Impella® 0052-3000Oscor Inc. · pacemaker lead Adaptor2 deaths19 reports
- Lead Adaptor BIS/BIS-40Oscor Inc. · pacemaker lead Adaptor14 reports
- NA 5866-38MMedtronic, Inc. · pacemaker lead Adaptor12 reports
- NA 5867-3MMedtronic, Inc. · pacemaker lead Adaptor10 reports
- Lead Adapter 501206Greatbatch Ltd · Pacemaker Lead Adaptor10 reports
- Lead Adapter 501214Greatbatch Ltd · Pacemaker Lead Adaptor9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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