BOND™ PA0009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05055331320421), received between Nov 7, 2023 and Jan 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A COMPLAINT WAS RECEIVED ON THE 3RD OF OCTOBER REGARDING FALSE POSITIVE STAINING RESULTS. BETWEEN SEPTEMBER 2022 AND JUNE 2023, 63 BREAST CANCER CASES WERE RETESTED AS THE LAB SUSPECTED FALSE POSITIVE ESTROGEN RECEPTOR RESULTS. THE RETESTING RESULTED IN A CHANGE IN THE INTERPRETATION OF 40 CASES, FROM POSITIVE TO NEGATIVE OR AT LEAST A DECREASE IN THE % POSITIVE NUCLEI IN TUMOUR CELLS. AT THE TIME THAT THIS COMPLAINT WAS SUBMITTED, BASED ON THE INITIAL INFORMATION RECEIVED REGARDING A LACK OF CONTROLS AND NOT FOLLOWING THE RECOMMENDED PROTOCOL, IT WAS DETERMINED THAT REPORTING WAS NOT REQUIRED FOR THIS ISSUE. FURTHER INFORMATION WAS RECEIVED ON THE 11TH OF DECEMBER 2023 AND IT WAS VERIFIED THAT 2 PATIENTS RECEIVED INAPPROPRIATE TREATMENT (POSSIBLY SURGERY) ON THE BASIS OF THE RESULTS, THIS ADDITIONAL INFORMATION TRIGGERED THE NEED FOR REPORTING. THE INFORMATION RECEIVED FOR PATIENT 2 IS OUTLINED BELOW: PATIENT 2 BORN IN 1959 BIOPSY (B)(6) 2022: NON-SPECIFIC CARCINOMA GRADE III KI-67 50% RE- (INITIALLY RE 50%+) RP- HER2 LUMPECTOMY AND SENTINEL LYMPH NODES: NON-SPECIFIC CARCINOMA GRADE III, PT1BN0 "PATIENT FOR WHOM ADJUVANT CHEMOTHERAPY WAS OFFERED BUT SHE REFUSED. HARM IS SUSPECTED

  Patient problems: Insufficient Information

  MAUDE report 18490357 ↗
• InjuryJan 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A COMPLAINT WAS RECEIVED ON THE 3RD OF OCTOBER REGARDING FALSE POSITIVE STAINING RESULTS. BETWEEN SEPTEMBER 2022 AND JUNE 2023, 63 BREAST CANCER CASES WERE RETESTED AS THE LAB SUSPECTED FALSE POSITIVE ESTROGEN RECEPTOR RESULTS. THE RETESTING RESULTED IN A CHANGE IN THE INTERPRETATION OF 40 CASES, FROM POSITIVE TO NEGATIVE OR AT LEAST A DECREASE IN THE % POSITIVE NUCLEI IN TUMOUR CELLS. AT THE TIME THAT THIS COMPLAINT WAS SUBMITTED, BASED ON THE INITIAL INFORMATION RECEIVED REGARDING A LACK OF CONTROLS AND NOT FOLLOWING THE RECOMMENDED PROTOCOL, IT WAS DETERMINED THAT REPORTING WAS NOT REQUIRED FOR THIS ISSUE. FURTHER INFORMATION WAS RECEIVED ON THE 11TH OF DECEMBER 2023 AND IT WAS VERIFIED THAT 2 PATIENTS RECEIVED INAPPROPRIATE TREATMENT (POSSIBLY SURGERY) ON THE BASIS OF THE RESULTS, THIS ADDITIONAL INFORMATION TRIGGERED THE NEED FOR REPORTING. THE INFORMATION RECEIVED FOR PATIENT 1 IS OUTLINED BELOW: PATIENT 1 BORN 1987 BREAST BIOPSY: GRADE III NON-SPECIFIC INFILTRATIVE CARCINOMA, KI-67 80%, INITIALLY RE60%+ RP- HER2 0, ER1 ER2 CONTROLS AND OTHER PLATFORM: NEGATIVE "UNDERGOING NEOADJUVANT CHEMOTHERAPY AND HAS NOT HAD IMMUNOTHERAPY AS RECOMMENDED FOR THIS TYPOLOGY. AFTER ADVICE FR

  Patient problems: Insufficient Information

  MAUDE report 18490351 ↗
• InjuryNov 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS OF THE THE 11TH OF DECEMBER, ADDITIONAL INFORMATION WAS RECEIVED REGARDING PATIENT TREATMENT, IT WAS INITIALLY SUGGESTED THAT THE TREATMENT OF TWO PATIENTS WAS AFFECTED BY THIS ISSUE HOWEVER THE ADDITIONAL INFORMATION RECEIVED SUGGESTS A TOTAL OF 12 PATIENTS MAY HAVE HAD TREATMENT AS A RESULT OF THE SUSPECTED FALSE POSITIVE RESULTS. TWO ADDITIONAL REPORTS WILL BE LOGGED FOR TWO OF THE PATIENTS UNDER THE REFERENCE (B)(4). THE INFORMATION REGARDING THE OTHER 10 PATIENTS IS STILL VERY LIMITED AND IS OUTLINED BELOW: (B)(6) HOSPITAL: 8 PATIENTS IN TOTAL. I HAVE NO PRECISE NOTION OF MEDICAL HARM. DEPENDING ON CPR FEEDBACK (NOT ALL PATIENTS HAVE YET BEEN PRESENTED). 1 PATIENT: PROBABLE HARM, DID NOT HAVE NEOADJ CHEMO, STOPPED HORMONAL THERAPY. 5 PATIENTS: DOUBT ABOUT CLINICAL CONSEQUENCE (PARTIAL TTT RESPONSES TO NEOADJ CHEMO OR NO NEOADJ CHEMO). 2 PATIENTS: HORMONAL THERAPY DISCONTINUATION. (B)(6) HOSPITAL: 2 PATIENTS: DOUBT ABOUT CONSEQUENCE (GERIATRIC REASSESSMENT). MEDICAL AFFAIRS ARE DUE TO HAVE A CALL WITH THE LABORATORY PATHOLOGIST TO DISCUSS THIS CASE AND DETERMINE ROOT CAUSE, A FOLLOW UP WILL BE SUBMITTED FOLLOWING THE SCHEDULED CALL.

  Patient problems: Insufficient Information

  MAUDE report 18088163 ↗