PILLING IPN915270Recalls & reported problems
Teleflex Incorporated · PUNCH DP-40K DISPOSABLE PUNCH 4.0 MILLIMETERS · Class 1
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 14026704697943), received between Aug 16, 2021 and Sep 17, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking6
- Mechanical Jam3
- Material Integrity Problem2
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information3
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT "WHEN COVERING THE PUNCH, A GREEN COLORED PARTICLE (THE COLOR OF THE CAP) WAS FOUND STUCK TO THE BEGINNING OF THE PUNCH, WHICH WAS GOING TO BE INSERTED INTO THE AORTA. SO THERE WAS A RISK OF MIGRATION INTO THE BLOODSTREAM. THE UTENSIL WAS WIPED WITH A DAMP COMPRESS. THE PARTICLE WAS SET ASIDE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074826 ↗MalfunctionSep 19, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED "IT WAS REPORTED THAT "DURING PROCEDURE, WHEN PUNCH WAS DEPRESSED, IT GOT STUCK AND WOULD NOT RETRACT BACK TO ORIGINAL POSITION". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. PLEASE SEE ASSOCIATED MDR# 3004365956-2024-00069
Patient problems: Insufficient Information
MAUDE report 20256856 ↗MalfunctionSep 19, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED "DURING PROCEDURE, WHEN PUNCH WAS DEPRESSED, IT GOT STUCK AND WOULD OTRETRACT BACK TO ORIGINAL POSITION.". THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 20256725 ↗MalfunctionMay 23, 2024
DEVICE WOULD STICK AND NOT PUNCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380415 ↗MalfunctionApr 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED "DISPOSABLE AORTIC PUNCH GETTING STUCK." ANOTHER PUNCH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19066161 ↗MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH GOT STUCK. AS A RESULT, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857410 ↗MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH GOT STUCK. AS A RESULT, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857373 ↗MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH GOT STUCK. AS A RESULT, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857323 ↗MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH GOT STUCK. AS A RESULT, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857026 ↗MalfunctionMar 7, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH GOT STUCK. AS A RESULT, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856947 ↗MalfunctionMar 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DISPOSABLE AORTIC PUNCH GOT STUCK. AS A RESULT, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856768 ↗MalfunctionFeb 29, 2024
AORTIC PUNCH DEVICE GETS STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18806476 ↗MalfunctionFeb 26, 2024
SEVEN REPORTS OF THE DISPOSABLE AORTIC PUNCH GETTING STUCK. EVENT DATE WITH LOT NUMBER: [DATE REDACTED]: #74G2301617; [1 WEEK AFTER 1ST EVENT]: #74G2301117; [10 DAYS AFTER 1ST EVENT] X2,: #74G2301617 AND #74H2300962; [2 WEEKS AFTER 1ST EVENT]: UNKNOWN LOT NUMBER, [17 DAYS AFTER 1ST EVENT]: #74H2300962, [29 DAYS AFTER 1ST EVENT]: UNKNOWN LOT NUMBER.
Patient problems: Insufficient Information
MAUDE report 18777033 ↗MalfunctionJan 8, 2024
DEVICE MALFUNCTIONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18463785 ↗MalfunctionNov 22, 2021Mechanical Jam; Mechanical Jam
THE CUSTOMER STATES THAT THE PUNCHED JAMMED WITH TISSUE ATTACHED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12856615 ↗MalfunctionAug 16, 2021Mechanical Jam; Mechanical Jam
WE HAVE HAD AN ISSUE IN THEATRE WITH THE DISPOSABLE AORTIC PUNCH. ON THE (B)(6) 2021 THE ITEM MALFUNCTIONED BY GETTING STUCK THEN NOT DEPLOYING. CLINICAL CONSEQUENCES: THE LOT NUMBER IS 74G2000344, WE HAVE REMOVED ALL OF THIS LOT NUMBER OFF OUR SHELVES JUST IN CASE IT'S A BATCH PROBLEM. THE SALES REPRESENTATIVE CONFIRMED THAT THE SAMPLE HAS BEEN DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12326000 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.