Prytime Medical Devices, Inc. PRP7226PRORecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850001105064), received between Nov 2, 2023 and Jan 21, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Difficult to Remove

  A REBOA CATHETER REQUIRED A SURGICAL CUTDOWN FOR REMOVAL FROM THE VESSEL. THE CASE INVOLVED A PATIENT WHO PRESENTED TO THE FACILITY AFTER SUSTAINING MULTIPLE GUN SHOT WOUNDS FROM AN AK-47. THE PATIENT SUSTAINED DEVASTATING INJURIES TO THE PELVIS, ILIAC VEIN AND ARTERY, IVC, DUODENUM, PANCREAS, AND COLON. A REBOA CATHETER WAS PLACED IN THE AORTA AND USED SUCCESSFULLY WITHOUT ISSUES FOR APPROXIMATELY 3-4 HOURS OF MOSTLY PARTIAL OCCLUSION WITH A SMALL AMOUNT OF FULL OCCLUSION. ONCE THE TRAUMA TEAM REPAIRED ALL OF THE INJURIES AND STABILIZED PATIENT, THE CATHETER WAS PREPARED FOR REMOVAL. THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE CATHETER THROUGH THE INTRODUCER SHEATH. VASCULAR PERFORMED A CUTDOWN TO REMOVE THE CATHETER AND SHEATH. VASCULAR THEN REPAIRED THE ARTERY.

  Patient problems: Vascular Dissection

  MAUDE report 24133316 ↗
• InjuryMay 17, 2024Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED A SURGICAL CUTDOWN FOR REMOVAL. THIS CASE INVOLVED A PATIENT WHO WAS PRESENTED TO THE FACILITY AFTER BEING INVOLVED IN A MOTOR VEHICLE COLLISION; THE PATIENT HAD BEEN PINNED BETWEEN TWO CARS. DURING TRANSPORT TO THE FACILITY, THE PATIENT ARRESTED; ROSC WAS ACHIEVED IN THE TRAUMA BAY. THE TEAM PLACED THE REBOA CATHETER IN ZONE 1 AND WAS USED SUCCESSFULLY WITHOUT ISSUES. THE PATIENT WAS TRANSFERRED TO THE OR FOR LIVER REPAIR AS IT WAS NOTED THAT THE PATIENT HAD A SEVERE LIVER LACERATION. ONCE THE PATIENT WAS STABLE AND HEMORRHAGE CONTROL WAS ACHIEVED, THE CATHETER WAS PREPARED FOR REMOVAL. UPON ATTEMPTED REMOVAL, THE TRAUMA SURGEON ENCOUNTERED DIFFICULTY IN REMOVING THE CATHETER THROUGH THE SHEATH. VASCULAR WAS CONSULTED, WHERE THEY RECOMMENDED AND PERFORMED A SURGICAL CUTDOWN TO REMOVE THE DEVICE. IN ADDITION, VASCULAR REPAIRED THE ARTERY AND ENSURED THAT PERFUSION WAS ESTABLISHED TO THE AFFECTED LIMB. NO COMPLICATIONS AT THE INSERTION SITE WERE REPORTED. PER THE REPORTING SURGEON, THE PATIENT IS ALIVE AND RECOVERING IN ICU. DURING INVESTIGATION OF THIS INCIDENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347206 ↗
• InjuryMar 29, 2024Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED A SURGICAL CUTDOWN FOR REMOVAL. THIS CASE INVOLVED A PATIENT WHO WAS PRESENTED TO THE FACILITY AFTER BEING INVOLVED IN A MOTORCYCLE COLLISION. THE PATIENT SUSTAINED A LIVER INJURY WITH NO ADDITIONAL DETAILS PROVIDED. THE FULL CASE WAS APPROXIMATELY TWO TO THREE HOURS LONG. THE REBOA CATHETER WAS SUCCESSFULLY USED DURING THE CASE, AND INVOLVED SEVERAL CYCLES FLUCTUATING BETWEEN COMPLETE OCCLUSION AND PARTIAL OCCLUSION. IT'S UNKNOWN WHERE THE ACCESS SITE WAS ESTABLISHED OR WHETHER THE CATHETER WAS PLACED IN ZONE 1 OR ZONE 3. AFTER THE PROCEDURE WAS COMPLETED, IN PREPARATION FOR REMOVAL OF THE CATHETER, THE IR SURGEON DEFLATED THE BALLOON USING A 20CC SYRINGE. UPON ATTEMPTED REMOVAL, BOTH THE TRAUMA SURGEON AND IR SURGEON REPORTED DIFFICULTY IN REMOVING THE CATHETER. A SURGICAL CUTDOWN WAS PERFORMED TO ENABLE EXTRACTION OF THE REBOA CATHETER AND THE INTRODUCER SHEATH AS A SINGLE UNIT IN ACCORDANCE WITH THE CATHETER INSTRUCTIONS FOR USE. A PORTION OF THE DEVICE WAS OBTAINED FROM THE FACILITY AND RETURNED TO PRYTIME FOR EVALUATION. SIGNIFICANT STRETCHING OF THE OUTER

  Patient problems: Insufficient Information

  MAUDE report 19003680 ↗
• InjuryJan 11, 2024Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED SURGICAL INTERVENTION FOR REMOVAL. THIS CASE INVOLVED A PATIENT WHO WAS PRESENTED TO THE FACILITY AFTER SUSTAINING INJURIES FROM A HIGH-SPEED MOTORCYCLE ACCIDENT. UPON ARRIVAL, THE PATIENT'S BLOOD PRESSURE WAS IN THE 80-90'S WITH HR IN THE 140'S. THE PATIENT WAS INTUBATED, AND A NEGATIVE FAST EXAM WAS OBTAINED. RIGHT FEMORAL ACCESS WAS GAINED AND A REBOA CATHETER WAS PLACED IN ZONE 1. PARTIAL OCCLUSION WAS PERFORMED FOR A CUMULATIVE TIME OF 25 MINUTES AND FULL OCCLUSION WAS PERFORMED FOR 25 MINUTES. A TOTAL OF THREE INFLATION/DEFLATION CYCLES WERE REQUIRED, AS THE PATIENT BECAME HYPOTENSIVE DURING DEFLATION. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO REMOVE THE CATHETER THROUGH THE SHEATH AND MET RESISTANCE. VASCULAR SURGERY WAS CONSULTED AND PERFORMED A SURGICAL CUTDOWN TO REMOVE THE CATHETER AND SHEATH AS A UNIT. NO COMPLICATIONS AT THE INSERTION SITE WERE REPORTED. DURING INVESTIGATION OF THIS INCIDENT, IT IS NOT KNOWN WHETHER ALL FLUID WAS REMOVED FROM THE BALLOON PRIOR TO ATTEMPTED REMOVAL. AS NOTED IN THE IFU, FAILURE TO REMOVE ALL

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18495232 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF THE REBOA CATHETER IN THE BLOODSTREAM, WHICH MAY HAVE CONTRIBUTED TO THROMBUS FORMATION REQUIRING A THROMBECTOMY AND FASCIOTOMY FOR TREATMENT. THE CASE INVOLVED A HYPOTENSIVE PATIENT WHO WAS PRESENTED TO THE FACILITY WITH AN UNCLEAR MECHANISM OF INJURY; THE PATIENT WAS FOUND NEAR TRAIN TRACKS, INDICATING A POSSIBLE PEDESTRIAN VS. TRAIN MOI. EARLY PERCUTANEOUS ACCESS WAS GAINED AT THE RIGHT COMMON FEMORAL ARTERY (CFA) USING A 5FR SHEATH. A DECISION WAS THEN MADE TO UPSIZE THE SHEATH AND PERFORM REBOA (SHEATH WAS UPSIZED TO A 7FR). THE REBOA CATHETER WAS PLACED IN ZONE-3 PRIOR TO PERFORMING A CT SCAN AND PARTIALLY OCCLUDED THE VESSEL FOR APPROXIMATELY 1 HOUR. FOLLOWING AORTIC OCCLUSION, THE CATHETER WAS DEFLATED IN THE OR AND MAINTAINED IN THE AORTA THROUGHOUT THE REMAINDER OF THE PELVIC SURGICAL PROCEDURE AND LEFT IN PLACE UNTIL THE END OF A SUBSEQUENT IR PROCEDURE AT WHICH POINT THE CATHETER WAS REMOVED. THE TOTAL TIME THE CATHETER AND SHEATH REMAINED IN THE VESSEL IS UNKNOWN. THERE WERE NO ISSUES ENCOUNTERED DURING ADVANCEMENT OF THE CATHETER THROUGH THE SHEATH, OR DURING USE OF THE CATHETER AND SHEA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18493705 ↗
• InjuryDec 13, 2023Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED A SURGICAL CUTDOWN FOR REMOVAL. THIS CASE INVOLVED A MALE PATIENT WHO PRESENTED TO THE FACILITY AFTER SUSTAINING MULTIPLE GUNSHOT WOUNDS TO THE ABDOMEN AND PELVIS. THE PATIENT WAS IMMEDIATELY SENT TO THE OR WHERE SIGNIFICANT BLEEDING FROM THE LIVER WAS IDENTIFIED, REQUIRING LIVER PACKING. WHILE IN THE OR, LEFT CFA ACCESS WAS OBTAINED VIA A 7FR SHEATH. AFTER A HEPATIC ARTERY EMBOLIZATION WAS CONDUCTED IN IR, THE PATIENT WAS TRANSFERRED TO SICU WHERE HE BEGAN TO SHOW SIGNS OF PROFUSE BLEEDING AND MTP WAS INITIATED. THE SURGEON REPORTED DIFFICULTY ADVANCING THE REBOA CATHETER INTO THE SHEATH AND USING SIGNIFICANT FORCE DURING INSERTION. THE CATHETER WAS ADVANCED TO ZONE 1 FOR APPROXIMATELY ONE HOUR; THE BALLOON WAS NEVER INFLATED AS THE PATIENT STABILIZED WITH BLOOD PRODUCTS. THE PATIENT WAS RETURNED TO THE OR, WHERE THE BALLOON WAS INFLATED AND PARTIALLY OCCLUDED FOR APPROXIMATELY ONE HOUR. AFTER THE OR PROCEDURES WERE COMPLETED, FULL DEFLATION OF THE BALLOON WAS ORDERED. UPON DEFLATION, THE SURGEON ATTEMPTED TO REMOVE THE DEVICE AND REALIZED THE CATHETER HAD A STR

  Patient problems: Vascular Dissection

  MAUDE report 18316967 ↗
• InjuryNov 7, 2023Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED A SURGICAL CUTDOWN FOR REMOVAL. THIS CASE INVOLVED A PATIENT WHO PRESENTED TO THE FACILITY AFTER SUSTAINING SIGNIFICANT CHEST INJURIES FROM A MOTORCYCLE ACCIDENT. THE PATIENT WAS HYPOTENSIVE UPON ARRIVAL AND WAS GIVEN 2 UNITS OF PRBCS AND 2 UNITS OF FFP. PER THE REPORTING SURGEON, THE PATIENT CONTINUED TO RAPIDLY DESATURATE. BILATERAL CHEST TUBES WERE PLACED, AND THE PATIENT WAS INTUBATED. ONCE THE PATIENT WAS SEMI-STABLE, THEY CONDUCTED A CT SCAN WHERE THE IMAGING REVEALED LEFT CHEST INJURIES WITH RIB FACTURES, QUESTIONABLE SPLENIC LACERATIONS (SPLEEN WAS ADJACENT TO A RIB FRACTURE), FRACTURES IN THE PUBIC SYMPHYSIS AND PUBIC RAMI AND A SMALL AMOUNT OF PELVIC BLOOD. THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP SO THE SURGEON DECIDED TO PERFORM REBOA. THE INITIAL SHEATH WAS EXCHANGED TO A 7FR SHEATH, AND THE CATHETER WAS INSERTED AND PLACED IN ZONE-3. THE CATHETER WAS THEN STITCHED TO THE PATIENT'S SKIN AND A DRESSING WAS APPLIED. AFTER THE CATHETER BALLOON WAS INFLATED AND PARTIALLY OCCLUDED FOR 40-MINUTES, FULL DEFLATION WAS ORDERED. UPON DEFLATION, THE SURGEON

  Patient problems: Vascular Dissection

  MAUDE report 18088909 ↗
• InjuryNov 6, 2023Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED SURGICAL INTERVENTION FOR REMOVAL. THIS CASE INVOLVED A PATIENT WHO WAS INITIALLY PRESENTED TO THE FACILITY AFTER SUSTAINING INJURIES FROM A MOTORCYCLE ACCIDENT, IN THE MORNING. LATER IN THE EVENING THE PATIENT DEVELOPED ABDOMINAL COMPARTMENT SYNDROME AND WAS TRANSFERRED TO THE OR. RIGHT FEMORAL ACCESS WAS GAINED AND A REBOA CATHETER WAS PLACED IN ZONE 1. THERE WERE NO ISSUES ENCOUNTERED DURING ADVANCEMENT OF THE CATHETER THROUGH THE SHEATH, OR DURING USE OF THE CATHETER FOR THE REBOA PROCEDURE. AFTER THE SURGERY PROCEDURE WAS COMPLETED, THE RESIDENT SURGEON ATTEMPTED REMOVAL OF THE CATHETER THROUGH THE SHEATH AND MET RESISTANCE. THE MAIN SURGEON NOTED THAT A 10CC SYRINGE WAS USED AND CHANGED TO A 30CC SYRINGE AND ATTEMPTED THE REMOVAL PROCEDURE WITHOUT SUCCESS. VASCULAR SURGERY WAS CONSULTED WHERE THEY PERFORMED A CUTDOWN TO REMOVE THE CATHETER AND SHEATH AS ONE UNIT. UPON INVESTIGATION OF THIS INCIDENT, IT WAS DETERMINED THAT THE LIKELY CAUSE OF REMOVAL DIFFICULTY MAY BE ATTRIBUTED TO USE-ERROR, AS IT IS NOT KNOWN WHETHER ALL FLUID WAS REMOVED FROM THE BALLOON

  Patient problems: Vascular Dissection

  MAUDE report 18077628 ↗
• InjuryNov 2, 2023Difficult to Remove; Difficult to Remove

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED SURGICAL INTERVENTION FOR REMOVAL. THE CASE INVOLVED A PATIENT WHO WAS PRESENTED AT THE FACILITY WITH A GUNSHOT WOUND. A SHEATH WAS PLACED IN THE RIGHT CFA IN PREPARATION FOR A REBOA PROCEDURE. THE BALLOON CATHETER WAS INSERTED INTO ZONE ONE AND INFLATED WITH PARTIAL OCCLUSION FOR THREE-HOURS. PER THE SURGEON, THEY CONDUCTED TWO CYCLES (CYCLIC INFLATION/DEFLATION) AS THE PROCEDURE WAS LENGTHY AND REQUIRED EXTENDED BALLOON INFLATION. THERE WERE NO ISSUES ENCOUNTERED DURING ADVANCEMENT OF THE CATHETER THROUGH THE SHEATH, OR DURING USE OF THE CATHETER FOR THE REBOA PROCEDURE. AFTER THE OPERATING PROCEDURE WAS COMPLETED, THE BALLOON CATHETER WAS DEFLATED AND PREPARED FOR REMOVAL. THE TRAUMA SURGEON REPORTED DIFFICULTY DURING ATTEMPTED REMOVAL OF THE CATHETER THROUGH THE SHEATH AND CONSULTED WITH THE VASCULAR DEPARTMENT. VASCULAR PERFORMED ALL REQUIRED STEPS FOR THE REMOVAL PROCESS AND STILL MET RESISTANCE. TO REMOVE THE CATHETER, THE VASCULAR SURGEON PROCEEDED WITH A VERTICAL INCISION AND REMOVED THE CATHETER AND SHEATH AS ONE UNIT. HE NOTED THAT SINCE HE DID NOT PUL

  Patient problems: Vascular Dissection

  MAUDE report 18062283 ↗