Micropuncture G02972Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002029729), received between Sep 13, 2016 and Jul 30, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084588 ↗
• MalfunctionJul 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, PRIOR TO USE FOR AN UNSPECIFIED INVASIVE PROCEDURE, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN A MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET'S SEALED PACKAGE. THE DEVICE WAS NOT USED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840619 ↗
• MalfunctionAug 8, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING A SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE-RETROGRADE INTERVENTION (SAFARI) PROCEDURE VIA RETROGRADE ACCESS IN THE FOOT, THE HUB OF A MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET'S SHEATH SEPARATED. THE LESION WAS REPORTEDLY DIFFICULT TO CROSS, REQUIRING MULTIPLE WIRES AND CATHETERS. PER THE USER, AT SOME POINT DURING THE PROCEDURE, THE HUB LOOKED LIKE IT WAS ALMOST DETACHED FROM THE SHEATH, SO THE SURGEON PROCEEDED TO REMOVE THE DEVICE, AT WHICH POINT THE HUB SEPARATED COMPLETELY, LEAVING THE SEPARATED SHEATH IN THE ACCESS SITE. SOME OF THE SHEATH WAS STILL VISIBLE AND WAS THEREFORE ABLE TO BE REMOVED FROM THE PATIENT WITH FORCEPS. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS CONTINUED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15184172 ↗
• MalfunctionJul 21, 2022Stretched; Stretched

  AS REPORTED, DURING A BELOW-THE-KNEE PERCUTANEOUS ANGIOPLASTY PROCEDURE VIA PEDAL ACCESS, THE DILATOR INCLUDED IN A MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET STRETCHED DURING INSERTION OF THE DEVICE. THE ACCESS SITE WAS NOT SCARRED. HOWEVER; A LITTLE RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE. ONCE THE DILATOR WAS IN THE PATIENT, THE USER REPORTED THAT THE SHAFT WAS FLOPPY, AS IF THE DILATOR HAD BENT AND STRETCHED OUT. THE DILATOR WAS REMOVED FROM THE PATIENT, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, WITHOUT FURTHER COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075616 ↗
• InjuryDec 3, 2021Break; Unraveled Material; Break; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12927305 ↗
• MalfunctionJul 8, 2021Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136134 ↗
• MalfunctionMay 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886771 ↗
• MalfunctionMar 4, 2020Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787501 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Sepsis

  MAUDE report 8598118 ↗
• MalfunctionApr 26, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8556641 ↗
• MalfunctionApr 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER OR AGE WITH A HISTORY OF DIABETES (TYPE NOT SPECIFIED), WAS UNDERGOING A PEDAL ANGIOGRAM INTERVENTION PROCEDURE ON AN UNKNOWN DATE. WHILE INTRODUCING THEM INTO A CALCIFIED DORSALIS PEDIS VESSEL, THE HUBS SEPARATED FROM THE INTRODUCERS OF TWO MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SETS OF THE SAME LOT. THE PROCEDURE WAS ABLE TO BE COMPLETED BY UPSIZING TO A FOUR FRENCH SHEATH (MANUFACTURER NOT SPECIFIED). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE, AND THEIR OUTCOME IS DESCRIBED AS "FINE". A PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S ANATOMY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. THE COMPLAINT DEVICES WERE DISCARDED AT THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8473745 ↗
• MalfunctionMar 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458731 ↗
• MalfunctionFeb 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8325319 ↗
• MalfunctionAug 23, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED, A MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET ARRIVED TO A DISTRIBUTOR WITH A PIECE OF FOREIGN MATERIAL INSIDE THE STERILE PACKAGING. THE DEVICE NEVER MADE IT TO A USER FACILITY AND NEVER MADE PATIENT CONTACT. NO ADVERSE EVENTS HAVE BEEN REPORTED FROM THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7810539 ↗
• MalfunctionDec 29, 2017Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT WHEN USING A MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET DEVICE DURING A "PERIPHERAL INTERVENTION FOR SUPERFICIAL FEMORAL ARTERY (SFA)" THE DEVICE SEPARATED. IT WAS WHEN THE MICROPUNCTURE SHEATH WAS BEING REMOVED THAT THE MATERIAL SEPARATED. IT WAS ALSO REPORTED THAT EVERYTHING WAS REMOVED FROM THE PATIENT WITHOUT ANY COMPLICATIONS OR ADDITIONAL PROCEDURES. NO UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, AND NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7155044 ↗
• MalfunctionOct 25, 2017Kinked; Split; Kinked; Split

  A MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET WAS USED IN A LOWER EXTREMITY RETROGRADE PEDAL INTERVENTION. IT WAS REPORTED THAT ACCESS WAS GAINED FOR RETROGRADE TIBIAL INTERVENTION BY ULTRASOUND. THE MICRO-PUNCTURE WIRE WAS FED THRU THE NEEDLE AND THE NEEDLE WAS REMOVED. THE MICRO-PUNCTURE SHEATH WAS INSERTED OVER THE WIRE AND THE DILATOR WAS REMOVED, THEN THE MICRO-PUNCTURE WIRE WAS REMOVED AND ANOTHER MANUFACTURERS .014 WIRE WAS INSERTED. A COOK .018 CXI WAS INSERTED OVER THE WIRE BUT COULD NOT ADVANCE PAST THE HUB OF THE MICRO-PUNCTURE SHEATH. THE SHEATH WAS REMOVED AND A KINK IN THE SHEATH WAS VISIBLE. THE TIP OF THE MICRO-PUNCTURE SHEATH WAS ALSO REPORTED TO HAVE DAMAGE. A SECOND MICRO-PUNCTURE ACCESS SHEATH WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978153 ↗
• InjuryMar 17, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SURGERY FOR ABDOMINAL ANGIOGRAM, ATHERECTOMY AND BALLOON ANGIOPLASTY, THE MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET, NITINOL WIRE GUIDE, BROKE OFF. THE SURGEON ACHIEVED TIBIAL ACCESS OF THE ANTERIOR TIBIAL ARTERY. THE HEAD OF THE GUIDE WIRE, INCLUDED WITHIN THE ANTERIOR TIBIAL ACCESS KIT, WHICH ALSO INCLUDES THE 4 FRENCH SHEATH, SHEARED OFF INTO THE TIBIAL ARTERY, WHICH WAS ALREADY OCCLUDED. THE SURGEON WAS ABLE TO RETRIEVE AND PULL THE WIRE OUT OF THE TIBIAL ARTERY, BUT THE WIRE BECAME LODGED IN THE SUBCUTANEOUS TISSUE. THE SURGEON ATTEMPTED TWICE TO REMOVE THE WIRE, BUT DEEMED THAT IT WAS UNSAFE TO REMOVE THE WIRE BLINDLY USING FLUOROSCOPY AND A HEMOSTAT. THE SURGEON DECIDED IT WAS SAFER TO LEAVE THE WIRE IN THE SUBCUTANEOUS TISSUE. THE SURGEON DID NOT PROCEED WITH THE ANTERIOR TIBIAL ARTERY REVASCULARIZATION. FURTHER INFORMATION WAS REQUESTED REGARDING THE PATIENT'S STATUS, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6413105 ↗
• InjuryNov 10, 2016Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN ATTEMPTING TO WITHDRAW THE GUIDE 0.18 MOUNTED ON THE 21G PUNCTURE NEEDLE, THE GUIDE JAMMED, FRAYED, THEN BROKE OFF. THE TIP REMAINED INSIDE OF THE PATIENT'S ANTERIOR TIBIAL ARTERY. A REQUEST FOR MORE INFORMATION AND IMAGES WAS SENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6093192 ↗
• InjurySep 13, 2016Material Separation; Material Separation

  IT WAS REPORTED DURING AN ANTERIOR TIBIAL BALLOON PROCEDURE, OF THE ANTERIOR TIBIAL, PEDAL ACCESS WAS USED AND WHEN THE SHEATH WAS PULLED IT WAS NOTED 2.5 CM OF THE SHEATH HAD BROKEN OFF. REPORTEDLY THE PHYSICIAN WAS CONSIDERING IRRIGATION AND DRAINAGE (I&D) TO REMOVE THE FRAGMENT, HOWEVER I&D WAS NOT DONE BECAUSE THE PATIENT MAY NEED TO HAVE AN AMPUTATION DUE TO ARTERIAL ISSUES AND I&D WOULD NOT BE NECESSARY . AS OF THE DATE OF THIS REPORT THE PATIENT OUTCOME AND IF THE SHEATH FRAGMENT HAS BEEN REMOVED ARE UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5946591 ↗