BioPince Ultra Full Core Biopsy Instrument 360-2080-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00886333224043), received between Dec 29, 2021 and Sep 25, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K904987); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jul 2, 2024Class IIOpen, Classified

   Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.

   Z-3192-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Liver biopsy to investigate histological changes consistent with immunotherapy-associated hepatitis. Loading/tensioning the Biopince was somewhat difficult but feasible (this issue occurs with nearly all Biopince biopsy needles). Dry firing/triggering was possible without any problems. Re-tensioning is possible. Sample collection with normal visibility on ultrasound. The punch cylinder should then be ejected. The tensioning required for ejection is very difficult but ultimately possible. During ejection, a small gray piece (presumably from inside the Biopince) breaks off and falls onto the sterile table. If the Biopince could not have been clamped open, the sample could not have been ejected and analyzed. In that case, a repeat biopsy would have been necessary. This would have carried an increased risk of bleeding, etc., since the first biopsy was performed without an over-needle closure technique, based on the assumption that only a single sample collection was necessary.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893144 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME - HOSPITALIZATION IN (B)(6) FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION).

  Patient problems: Insufficient Information

  MAUDE report 18322938 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE MOOREA HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCEPHIN AT HOME - HOSPITALIZATION IN CARDELLA FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCEPHIN AMIKIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION).

  Patient problems: Insufficient Information

  MAUDE report 18322767 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE MOOREA HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCEPHIN AT HOME - HOSPITALIZATION IN CARDELLA FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION ,- A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION).

  Patient problems: Insufficient Information

  MAUDE report 18322662 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  (B)(4). 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER. - PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME. - HOSPITALIZATION IN CARDELLA FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION. - A SURVEY FOR ACUTE URINE RETENTION. - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER. - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION.

  Patient problems: Insufficient Information

  MAUDE report 18322636 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME - HOSPITALIZATION IN (B)(6) FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION)

  Patient problems: Insufficient Information

  MAUDE report 18322610 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME - HOSPITALIZATION IN (B)(6) FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION. - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER. - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION)

  Patient problems: Insufficient Information

  MAUDE report 18322580 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME HOSPITALIZATION IN CARDELLA FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKACIN, 4 DAYS OF HOSPITALIZATION A SURVEY FOR ACUTE URINE RETENTION A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER URETHRORRHAGIA GIVING IN TO HYPER HYDRATION.

  Patient problems: Insufficient Information

  MAUDE report 18322511 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE MOOREA HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCEPHIN AT HOME - HOSPITALIZATION IN CARDELLA FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCEPHIN AMIKIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION)

  Patient problems: Insufficient Information

  MAUDE report 18322483 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  (B)(4). 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER. - PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME. - HOSPITALIZATION IN CARDELLA FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION. - A SURVEY FOR ACUTE URINE RETENTION. - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER. - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION.

  Patient problems: Insufficient Information

  MAUDE report 18322289 ↗
• InjuryDec 13, 2023Failure to Obtain Sample; Failure to Obtain Sample

  OUT OF 16 BIOPSIES, THERE WERE 10 INCIDENTS. 5 TIMES THE GUN FAILED AFTER TWO OR THREE USES, MAKING VACUUM PUNCTURES WITHOUT BRINGING BACK PIECES OF TISSUE, WHICH INCREASES THE ATTACK ON THE PROSTATE AND THEREFORE THE RISK OF HEMORRHAGE AND INFECTION AND WHICH REQUIRED FOR ONCE, 7 GUNS TO MAKE 12 CARROTS (ON AVERAGE 2) 6 TIMES THE PROCEDURE WAS FOLLOWED BY HOSPITALIZATION OR CONSUMPTION OF HEAVY TREATMENT. - A NIGHT HOSPITALIZATION AT THE (B)(6) HOSPITAL FOR THE SAME SITUATION OF HEMORRHAGE/CATHETERIZATION WITH A WEEK OF HOSPITALIZATION FOR A FRAGILE GRANDFATHER - PROSTATITIS WITH PRESCRIPTION OF ROCÉPHINE AT HOME - HOSPITALIZATION IN (B)(6) FOR SEVERE PROSTATITIS BORDERING ON SEPTIC SHOCK THE SAME EVENING OF THE PUNCTURE, ROCÉPHINE AMIKLIN, 4 DAYS OF HOSPITALIZATION - A SURVEY FOR ACUTE URINE RETENTION - A HEMATOMA RESPONSIBLE FOR DYSURIA, PRESCRIPTION OF BACTRIM AND ALPHA BLOCKER - URETHRORRHAGIA GIVING IN TO HYPER HYDRATION. (SEE BELOW FOR NOTES/ ADDITIONAL INFORMATION).

  Patient problems: Insufficient Information

  MAUDE report 18321870 ↗
• MalfunctionMar 31, 2022Activation Problem

  PHYSICIAN REPORTS THAT DURING THE USE OF THE DEVICE, THE 2 TRIGGERS OF THE DEVICE ARE TOO HARD TO ACTIVATE AND NO SAMPLE IS OBTAINED IN 3 GYNECOLOGICAL BIOPSY PROCEDURES. THE HOSPITAL RETURNS 5 UNUSED UNITS. FROM THE SAME BATCH. HOSPITAL NEEDS A LETTER EXPLAINING THE ROOT CAUSE OF THE INCIDENT AND WACREES NEEDS CREDIT NOTE PER 5 UNITS OF THE SAME REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13970512 ↗
• MalfunctionDec 29, 2021Device Slipped

  THE ADJUSTED LENGTH OF THE BIOPINCE ULTRA 18G 20 DEVICE DIDN'T STAY AS ADJUSTED AND NEEDED AT 23MM. WHEN TAKING THE BIOPSY THE THROW LENGTH CHANGED TO 33MM. LUCKILY THIS DIDN'T CAUSE AN ISSUE HOWEVER THERE WAS A HUGE SURPRISE TO THE OPERATOR AND COULD HAVE BEEN VERY DANGEROUS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K904987. One submission often covers many models, so check the product and lot details in each record.

• Z-2427-2020 · Dec 2, 2019 · Terminated
  BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Ins