Temporary Myocardial Heartwire TME 64 SRecalls & reported problems
Oscor Inc. · Class 2
Data updated Oct 18, 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 00836559001782), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Retroperitoneal Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT A RETROPERITONEAL BLEED WAS SUSPECTED WITH A FEMALE PATIENT. THE PROCEDURE WAS COMPLETED WHILE MONITORING THE SITE AND LABS; ANTICOAGULATION MEDS WERE REVERSED. THE PATIENT WAS STABLE AT THE TIME OF THE CALL AND AWAITING A SURGICAL CONSULT. THE PATIENT WAS PROVIDED SURGICAL INTERVENTION TO LOCATE THE BLEED SITE. THE PATIENT WAS GIVEN IV HEPARIN TO REVERSE THE ANTICOAGULATION AND WAS KEPT IN THE HOSPITAL FOR AN EXTENDED TIME PERIOD AND HAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE DEVICE WAS IN USE FOR APPROPRIATELY 25 MINS. THE RETROPERITONEAL BLEED WAS CONFIRMED.
Patient problems: Retroperitoneal Hemorrhage
MAUDE report 10800100 ↗
Other Electrode, Pacemaker, Temporary devices
- N/A 006173PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY161 reports
- SWAN-GANZ D200F7Edwards Lifesciences LLC · ELECTRODE, PACEMAKER, TEMPORARY1 recall0 reports
- ETHICON TPW32Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY1 death46 reports
- ETHICON TPW20Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY39 reports
- N/A 520007PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY33 reports
- Pacel™ 401763St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY21 reports
- Pacel™ 401771St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY1 death16 reports
- SWAN-GANZ PACING TD CATHETER D205F7Edwards Lifesciences LLC · Electrode, Pacemaker, Temporary13 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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