Bridge Prep KitRecalls & reported problems across all models

We found 4 models of Bridge Prep Kit by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jul 23, 2020 and Nov 10, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bridge Prep Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 2, 2026Open, Classified

   catheter may experience resistance when being advanced over the guidewire

   Z-2003-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Apr 2, 2026Open, Classified

   catheter may experience resistance when being advanced over the guidewire

   Z-2002-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jun 11, 2024Open, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2567-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported Bridge Prep Kit problems

Bridge Prep Kit models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bridge™ Prep Kit 00884450816509

  Angiography/angioplasty kit
  2 recalls0 reports
• Bridge™ Prep Kit 00884450771310

  Angiography/angioplasty kit
  1 recall1 report
• Bridge™ Prep Kit 00884450843024

  Angiography/angioplasty kit
  3 reports
• Bridge™ Prep Kit 00884450294819

  Angiography/angioplasty kit
  2 reports

Recent Bridge Prep Kit adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem

  THE ACCOUNT ALLEGES THE 12F INTRODUCER FELL APART WHILE REMOVING THE DEVICE FROM THE WIRE FROM WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510632 ↗
• MalfunctionJul 22, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE 12F SHEATH TORE AT THE DISTAL TIP ON A PRE-DILATED PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571918 ↗
• MalfunctionJul 22, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE 12F SHEATH TORE AT THE DISTAL TIP ON A PRE-DILATED PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571916 ↗
• InjuryFeb 20, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT A BRIDGE GUIDE WIRE FROM ONE OF THE PREP KITS BROKE APART INSIDE THE PATIENT. THE TIP OF THE WIRE GOT STUCK IN THE IVC AND WHEN THE EP EXTRACTOR PULLED BACK THE GUIDE WIRE IT SLINKIED APART. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE PIECE THAT BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 21420479 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A (B)(6)-YEAR-OLD FEMALE PATIENT ON DIALYSIS, PRESENTED AT (B)(6) HOSPITAL, (B)(6), ON (B)(6) 2020 WITH A RECURRENT BACTEREMIA INFECTION. THE PATIENT WAS IMPLANTED WITH A ST. JUDE 7120, DUAL-COIL ICD LEAD ON (B)(6) 2013. THE PHYSICIAN BEGAN THE CASE BY GAINING VENOUS ACCESS IN THE LEFT FEMORAL VEIN WITH THE 12F SHEATH INCLUDED IN THE OCCLUSION BALLOON. (THE RIGHT FEMORAL VEIN WAS OCCLUDED DUE TO A DIALYSIS CATHETER) AND THEN ADVANCED THE GUIDEWIRE THROUGH THE SHEATH AND INTO THE IVC AND ON THROUGH TO THE SVC. IT WAS APPARENT THAT THERE WAS SIGNIFICANT CALCIFICATION [DISEASE] WITHIN THE SVC AND AROUND THE SVC LEADS COIL. THE GUIDEWIRE INITIALLY WOULD NOT ADVANCE PAST THE MID-SVC AFTER SEVERAL ATTEMPTS. THE PHYSICIAN LOADED AN OCCLUSION BALLOON ONTO THE WIRE AND ADVANCED IT TO THE AREA OF STALLED PROGRESSION [MID SVC]. THE BALLOON SERVED AS SUPPORT FOR THE WIRE AND WAS SUFFICIENT THAT THE WIRE FINALLY FOUND A CHANNEL TO ADVANCE THROUGH. ACCESS WAS COMPLETED AT THE RIGHT SUBCLAVIAN VEIN, WHERE THE PHYSICIAN WAS ABLE TO ADVANCE AND FINALLY ANCHOR THE GUIDEWIRE AND THE OCCLUSION BALLOON INTO POSITION AT THE RA/SVC JUNCTION. A PRE-INFLATION WITH APPROXIMATELY 10C

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 11135954 ↗
• MalfunctionJul 23, 2020Malposition of Device; Malposition of Device

  THE ACCOUNT ALLEGES THAT DURING A SUCCESSFUL LEAD EXTRACTION PROCEUDRE, THE PATIENT WAS STABLE AND THE POCKET WAS CLOSED. WHEN THE 12F INTRODUCER SHEATH WAS REMOVED FROM THE GROIN AFTER THE PROCEDURE, BLEEDING WAS NOTICED IN THE AREA. VASCULAR SURGEON DISCOVERED AN INJURY IN THE RIGHT COMMON ILIAC ARTERY. THE ACCOUNT ALLEGES THAT THE NEEDLE CONTAINED WITHIN THE BRIDGE ACCESSORY KIT PUNCTURED BOTH THE FEMORAL VEIN AND THE ARTERY DURING PREPARATION FOR PROPHYLACTIC STAGING OF THE BRIDGE BALLOON PRIOR TO THE CASE, AND THAT THE 12F INTRODUCER SHEATH PROVIDED TAMPONADE TO THE INJURY DURING THE ACTUAL PROCEDURE. ONLY AFTER THE 12F INTRODUCER SHEATH WAS REMOVED WAS THE INJURY DETECTED. IT HAS BEEN REPORTED THAT THE RIGHT COMMON ILIAC ARTERY WAS STENTED AND THE PATIENT SURVIVED THE PROCEDURE. THERE WAS NO ALLEGED MALFUNCTION OF THE BRIDGE BALLOON, NOR DID THE BRIDGE BALLOON ITSELF CONTRIBUTE TO A SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317257 ↗

Other Merit Medical Systems, Inc. products

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