Reocor D 365529Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035479110055), received between Oct 12, 2018 and Jan 25, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “No Pacing” (4 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2022Device Sensing Problem; Adverse Event Without Identified Device or Use Problem; Device Sensing Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS EXTERNAL DEVICE SENSED INCORRECTLY AND PACED INAPPROPRIATELY CAUSING A VENTRICULAR ARRHYTHMIA IN A POSTOPERATIVE PATIENT. THE DEVICE WAS PUT ASIDE AND RETURNED FOR ANALYSIS.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342707 ↗
• InjuryOct 12, 2018No Pacing; No Pacing

  WE RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA. THE REPORT WAS SENT IN FROM (B)(6) HEALTH ((B)(4)). THE REPORT IS: WHEN A (B)(6) YEAR OLD MALE WAS AT A CRITICAL TIME IN THE SURGERY THE EXTERNAL PACEMAKER AND CABLE FAILED TO PROPERLY FUNCTION. THE PATIENT'S HEART QUICKLY DISTENDED AND A HOLE WAS EMERGENTLY MADE IN THE HEART TO DECOMPRESS THE HEART IN ORDER TO SAVE THE PATIENT. ONCE A PROPER FUNCTIONING CABLE AND BOX WERE RETRIEVED (2 BOXES LATER), THE HOLE THAT WAS EMERGENTLY MADE NEEDED TO BE FIXED. (B)(6) HEALTH CANNOT PROVIDE THE SERIAL NUMBERS OF THE EXTERNAL PACEMAKERS THAT WERE USED. (B)(6) HEALTH CLAIMED THAT THE DEVICES WERE SENT TO THEIR BIOMED GROUP WHERE THEY TESTED FINE AND WERE NOT RETURNED TO BIOTRONIK.

  Patient problems: No Code Available

  MAUDE report 7962354 ↗
• InjuryOct 12, 2018No Pacing; No Pacing

  WE RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA. THE REPORT WAS SENT IN FROM (B)(6) ((B)(4)). THE REPORT IS: WHEN A (B)(6) MALE WAS ON CARDIOPULMONARY BYPASS THE PHYSICIAN WENT THROUGH TWO EXTERNAL PACEMAKERS, 3 PACING CABLES AND 2 PACING LEADS IN ORDER TO GET A PACED RHYTHM. THIS RESULTED IN THE PATIENT BEING ON CARDIOPULMONARY BYPASS AN EXTRA 10 MINUTES AND AN EXTRA STITCH IN THE HEART. BIOTRONIK ATTEMPTED TO GET THE SERIAL NUMBER OF THIS DEVICE UNDER COMPLAINT WITH NO SUCCESS. THE HOSPITAL CLAIMED THAT THE EXTERNAL PACEMAKERS WERE SENT TO THEIR BIOMED TEAM WHERE THEY PASSED MANUFACTURE SPECS. THE HOSPITAL DOES NOT BELIEVE THEY WERE SENT BACK TO BIOTRONIK FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 7962319 ↗
• InjuryOct 12, 2018No Pacing; No Pacing

  WE RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA. THE REPORT WAS SENT IN FROM (B)(6) HEALTH ((B)(4)). THE REPORT IS: WHEN AN (B)(6) YEAR OLD MALE WAS BEING TAKEN OFF THE BYPASS MACHINE AND THE TEAM WAS TRYING TO GET HIS HEART STARTED AGAIN, PACING WIRES WERE INSERTED INTO THE HEART AND CONNECTED TO THE PACING CABLES AND TO THE EXTERNAL PACEMAKER. THE PACING DIDN'T WORK WITH THE FIRST SET OF CABLES AND EXTERNAL PACEMAKER. THE CABLES WERE CHANGED OUT WITH STILL NO CHANGE. THE EXTERNAL PACEMAKER WAS CHANGED OUT WITH STILL NO PACING. EVERYTHING WAS CHANGED OUT 3 TIMES WITH NO SUCCESS. FINALLY THE PHYSICIAN USED A COMPETITOR'S DEVICE AND CABLES AND PACING WAS ACHIEVED. THE HOSPITAL COULD NOT PROVIDE ANY SERIAL NUMBERS IN THIS COMPLAINT. THEY ALSO SAID THAT THE DEVICES WERE RETURNED TO THEIR BIOMED DEPARTMENT AND ALL DEVICES CHECKED OUT FINE.

  Patient problems: No Code Available

  MAUDE report 7962318 ↗
• InjuryOct 12, 2018No Pacing; No Pacing

  WE RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA. THE REPORT WAS SENT IN FROM (B)(6) HEALTH ((B)(4)). THE REPORT IS: WHEN A (B)(6) YEAR OLD MALE WAS BEING TAKEN OFF CARDIO-PULMONARY BYPASS AN EXTERNAL PACEMAKER WAS NEEDED. WHEN THE PACEMAKER WAS TURNED ON, IT JUST FLASHED ALL THE LIGHTS AND WOULD NOT PACE. THE NURSE HAD TO RUN OUT OF THE ROOM FOR ANOTHER PACEMAKER. THE MALFUNCTIONING PACEMAKER DELAYED PATIENT CARE AND EXTENDED THE CARDIO-PULMONARY BYPASS TIME. THE DEVICE WAS SENT TO THE HOSPITAL'S BIOMED TEAM WHERE THE DEVICE PASSED ALL THE MANUFACTURE SPECS. THEY DID NOTICE THAT THE MODE TURN KNOB WAS HARD TO TURN SO THEY DECIDED TO EXCHANGE THE DEVICE. THE SERIAL NUMBER OF THIS DEVICE UNDER COMPLAINT WAS NOT PROVIDED BY THE HOSPITAL. THE HOSPITAL HAS ALSO SAID THAT THIS DEVICE WAS NOT RETURNED FOR AN ANALYSIS. IT IS UNCLEAR IF THE DEVICE WAS RETURNED OR NOT.

  Patient problems: No Code Available

  MAUDE report 7962121 ↗