M/IS-10Recalls & reported problems
Oscor Inc. · Class 2 · Implant
Data updated Oct 16, 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 00836559006091), received between Dec 31, 2024 and Dec 31, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “High Capture Threshold” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- High Capture Threshold1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold
HIGH GRADE AV BLOCK. RISING RV THRESHOLD ON 5032-58CM LEAD. SYSTEM EXTRACTION WITH REIMPLANT PLANNED. DR. (B)(6) DECIDED TO EXTRACT ALL LEADS (ABANDONED AND ACTIVE) AND START OVER WITH A NEW SYSTEM. PATIENT OUTCOME: ALIVE - NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046932 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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