Zebra AC7087-095-20-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00857545008219), received between Mar 4, 2025 and Aug 26, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50464562 ↗
• MalfunctionMay 28, 2026Break

  ON (B)(6) 2026, DURING A NEUROVASCULAR PROCEDURE PERFORMED VIA FEMORAL ACCESS, A ZEBRA 7F 95 CM CATHETER WAS UTILIZED WITH A CORDIS 5F SIM 125 CM DIAGNOSTIC CATHETER WHILE NAVIGATING TORTUOUS ILIAC ANATOMY AND TRACKING ACROSS THE AORTIC ARCH. DURING USE, RESISTANCE WAS REPORTEDLY ENCOUNTERED AND SALINE LEAKAGE WAS OBSERVED FROM A KINKED REGION OF THE ZEBRA CATHETER APPROXIMATELY 1 INCH DISTAL TO THE STRAIN RELIEF SEGMENT. THE SIM CATHETER WAS SUBSEQUENTLY IDENTIFIED TO BE FRACTURED WITHIN THE ZEBRA CATHETER. THE PROXIMAL PORTION OF THE SIM CATHETER WAS REMOVED, AFTER WHICH THE ZEBRA CATHETER WAS PARTIALLY WITHDRAWN AND CUT TO EXPOSE THE RETAINED SIM CATHETER SEGMENT. THE ZEBRA AND RETAINED SIM CATHETER SEGMENT WERE THEN CLAMPED TOGETHER AND REMOVED SIMULTANEOUSLY FROM THE PATIENT. THE SEPARATED SIM CATHETER SEGMENT REMAINED ACCESSIBLE OUTSIDE THE PATIENT VASCULATURE; REMOVAL WAS COMPLETED WITHOUT INVASIVE RETRIEVAL OR SURGICAL INTERVENTION, NO RETAINED FRAGMENTS REMAINED IN THE PATIENT, AND NO PATIENT INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS REPORTED. THE PHYSICIAN SUBSEQUENTLY CONVERTED TO ANOTHER CATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319738 ↗
• InjuryMay 26, 2026Break

  DURING A NEUROVASCULAR PROCEDURE PERFORMED ON (B)(6) 2026 VIA RIGHT RADIAL ACCESS, A ZEBRA 7F 95 CM SIM2 CATHETER WAS REPORTEDLY ADVANCED THROUGH TORTUOUS ANATOMY INVOLVING A SHARP INNOMINATE ARTERY TAKEOFF. RESISTANCE WAS REPORTEDLY ENCOUNTERED DURING ADVANCEMENT AND WITHDRAWAL. DURING REMOVAL, A KINK WAS REPORTEDLY OBSERVED ALONG THE DISTAL SHAFT OF THE CATHETER. WHILE WITHDRAWING THE DEVICE, THE CATHETER REPORTEDLY SEPARATED NEAR THE PROXIMAL SHAFT REGION, RESULTING IN SEPARATION INTO TWO PIECES. THE DISTAL CATHETER SEGMENT REPORTEDLY REMAINED PARTIALLY WITHIN THE PATIENT VASCULATURE AND WAS PHYSICIAN INTERVENTION WAS REQUIRED TO REMOVE THE RETAINED CATHETER SEGMENT FROM THE PATIENT VASCULATURE. THE PHYSICIAN REPORTEDLY RE-ACCESSED THE PATIENT AND COMPLETED THE PROCEDURE SUCCESSFULLY USING A DIFFERENT CATHETER. THE PATIENT OUTCOME WAS REPORTED STABLE POST-PROCEDURE. THE RETURNED DEVICE WAS RECEIVED FOR EVALUATION IN TWO SEPARATED PIECES. VISUAL EXAMINATION CONFIRMED CATHETER SEPARATION APPROXIMATELY 2.5 CM DISTAL TO THE STRAIN RELIEF. THE RETURNED CATHETER LENGTH WAS CONSISTENT WITH MANUFACTURED SPECIFICATION AND NO SIGNIFICANT ELONGATION WAS IDENTIFIED. ADDITIONAL SHAFT BENDS/D

  Patient problems: Insufficient Information

  MAUDE report 25280527 ↗
• MalfunctionMay 7, 2026Fracture

  THE CUSTOMER REPORTED THAT DURING PREPARATION FOR A NEUROVASCULAR PROCEDURE ON (B)(6) 2026, A ZEBRA 7F 95 CM SIM2 CATHETER WAS REMOVED FROM THE PRODUCT PACKAGING AND PREPARED FOR USE. THE SCRUB TECHNICIAN REPORTEDLY FLUSHED THE CATHETER WHILE IT REMAINED WITHIN THE PROTECTIVE TUBING, AND RESISTANCE WAS NOTED DURING FLUSHING. AFTER REMOVAL FROM THE PROTECTIVE TUBING, A DISTAL SHAFT KINK WAS REPORTEDLY OBSERVED. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT USED FOR PATIENT TREATMENT, AND AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT REPORTED PATIENT INJURY OR ADVERSE CLINICAL OUTCOME. THE DEVICE WAS RETURNED TO Q'APEL MEDICAL ON 4/20/2026 AND UNDERWENT PRODUCT EVALUATION ON 4/23/2026. THE RETURNED PRODUCT EVALUATION IDENTIFIED FINDINGS THAT ARE INCONSISTENT WITH THE REPORTED EVENT DESCRIPTION. VISUAL INSPECTION IDENTIFIED A SEVERE PROXIMAL SHAFT KINK/FRACTURE APPROXIMATELY 10-11 CM FROM THE HUB/STRAIN RELIEF. WHEN FLUSHING THE CENTRAL LUMEN, LEAKAGE FROM THE FRACTURED REGION CONFIRMED A LUMEN BREACH. ADDITIONALLY, BLOOD WAS OBSERVED EXITING THE DISTAL TIP OF THE CENTRAL LUMEN DURING FLUSHING, SUGGESTING THE DEVICE MAY HAVE BEEN EXPOSED TO BLOOD OR I

  Patient problems: Insufficient Information

  MAUDE report 25117588 ↗
• MalfunctionFeb 23, 2026Fracture

  ON JANUARY 23, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A 7F 95 CM SIM 2 ZEBRA CATHETER DURING A MECHANICAL THROMBECTOMY PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS. THE CATHETER WAS PREPARED AND FLUSHED PER THE INSTRUCTIONS FOR USE AND ADVANCED TO THE HIGH CERVICAL INTERNAL CAROTID ARTERY. TWO THROMBECTOMY PASSES WERE PERFORMED USING ADJUNCTIVE DEVICES. TICI 3 REVASCULARIZATION WAS ACHIEVED. UPON WITHDRAWAL OF THE ZEBRA CATHETER THROUGH THE SHEATH, A PARTIAL SHAFT FRACTURE WAS OBSERVED. NO RESISTANCE OR UNUSUAL MANIPULATION WAS REPORTED DURING USE OR REMOVAL. NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. RETURNED PRODUCT EVALUATION CONFIRMED A CATHETER SHAFT BREACH APPROXIMATELY 19 CM FROM THE DISTAL TIP, CHARACTERIZED BY POLYMER JACKET AND LINER SEPARATION. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL LASER-CUT TUBE (LCT) STRUT PATTERN, PITCH VARIATION, OR GEOMETRIC IRREGULARITY. THE DISTAL TIP SHOWED NO ABNORMALITIES. NO EVIDENCE OF MANUFACTURING NONCONFORMANCE, MATERIAL DEFECT, OR SYSTEMIC DESIGN DEFICIENCY WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411116 ↗
• MalfunctionJan 14, 2026Fracture

  ON (B)(6) 2025, DURING A RADIAL ACCESS PROCEDURE, THE PHYSICIAN OBSERVED BLOOD ESCAPING FROM THE HUB OF A ZEBRA CATHETER DURING USE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ZEBRA CATHETER, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT FURTHER INCIDENT. A CUSTOMER-PROVIDED IMAGE TAKEN AT THE TIME OF THE EVENT SHOWED THE CATHETER INTACT IN ONE PIECE WITH A LOCALIZED SURFACE DISCONTINUITY (FRACTURE) JUST DISTAL TO THE STRAIN RELIEF. THE USER REPORTED THAT NO RESISTANCE OR TORQUING WAS ENCOUNTERED DURING USE. EVALUATION OF THE RETURNED DEVICE SHOWED THAT THE CATHETER WAS FRACTURED JUST DISTAL TO THE STRAIN RELIEF (1-2 MM), A LOCATION THAT EXPERIENCES ELEVATED MECHANICAL STRESS WHEN SUBJECTED TO TIGHT-RADIUS BENDING OR OFF-AXIS LOADING. NO EVIDENCE OF DESIGN OR MANUFACTURING NONCONFORMANCE (E.G., IMPROPER LAMINATION, ABNORMAL FEED GAP, EXPOSED REINFORCEMENT, OR STRUCTURAL ANOMALY) WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24076640 ↗
• MalfunctionOct 23, 2025Break; Break

  ON (B)(6) 2025, DURING A RIGHT RADIAL ACCESS TO LEFT CAROTID ARTERY STENTING PROCEDURE, THE PHYSICIAN USED A 6F SHEATH AND A SELECT CATHETER TO ACCESS THE CAROTID ARTERY. AFTER SUCCESSFUL DILATION, THE PHYSICIAN EXCHANGED THE SYSTEM FOR A 7F ZEBRA CATHETER, REMOVING THE 6F SHEATH. THE CAROTID STENT WAS SUCCESSFULLY PLACED. UPON REMOVAL OF THE 7F ZEBRA CATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE RADIAL ARTERY, NOTING A LIKELY VASOSPASM. UPON CONTINUING WITHDRAWAL OF THE DEVICE, THE CATHETER SEPARATED OUTSIDE THE PATIENT. A SUBSEQUENT ATTEMPT TO REMOVE THE REMAINING SEGMENT RESULTED IN A SECOND EXTERNAL BREAK, AFTER WHICH THE REMAINING CATHETER WAS FULLY RETRIEVED. FLUOROSCOPIC IMAGING CONFIRMED NO RETAINED FRAGMENTS OR ARTERIAL DAMAGE. THE ACCESS SITE WAS CLOSED WITH A TR BAND. THE PATIENT REMAINED STABLE AND EXPERIENCED NO COMPLICATIONS. THE DEVICE WAS RETURNED AND RECEIVED BY THE MANUFACTURER, CONSISTING OF THREE CATHETER SEGMENTS WITH NO MISSING PORTIONS IDENTIFIED. FAILURE ANALYSIS OF THE REPORTED EVENT WAS PERFORMED. THE RETURNED ZEBRA 7F CATHETER FRACTURED IN TWO LOCATIONS, EXHIBITING CLEAR SIGNS OF STRETCHING ALONG MULTIPLE FRACTURE SITES AS A RESULT OF EXCESSIVE PU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373159 ↗
• MalfunctionMar 4, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ANY REQUIRED FIELDS THAT REMAIN UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. Q'APEL MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. Q'APEL MEDICAL MADE MULTIPLE GOOD-FAITH EFFORTS TO COMMUNICATE WITH THE PHYSICIAN TO GATHER MORE INFORMATION REGARDING THE EVENT AND THE PHYSICIAN PERFORMING CASE CONFIRMED THE INFORMATION STATED BELOW. PATIENT DETAILS-NOT PROVIDED, PATIENT AGE: NOT PROVIDED, PATIENT SEX: NOT PROVIDED, MEDICAL CONSIDERATIONS: SCARRED GROIN. PROCEDURE DETAILS: NO SHEATH WAS USED INITIALLY A 6FR VASCULAR DILATOR FOLLOWED BY A 7FR PRE-DILATOR WAS USED AFTER NEEDLE PUNCTURE, MICRO PUNCTURE, AND 0.035" WIRE INSERTION A Q'APEL DILATOR WAS USED WITH A 7FR ZEBRA CATHETER DUE TO THE ABSENCE OF A SHEATH, THE CATHETER WAS INSERTED MANUALLY, INCH BY INCH SOME BACK PRESSURE WAS NOTED DURING INSERTION A DIAGNOSTIC CATHETER WAS INSERTED INTO THE ZEBRA AFTER DILATOR REMOVAL OVER THE WIRE. ISSUE ENCOUNTERED: UNDER FLUOROSCOPY, THE DIAGNOSTIC CATHETER DID NOT MOVE WITH THE ZEBRA AS EXPECTED AFTER APPROXIMATELY TWO MINUTES, ACTIVE BLEEDING ("PINHOLE") FROM THE SIDE OF THE CATHETER WAS OBSERVED AT THE GR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515859 ↗