TEMPO SRD5559Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705032048545), received between Mar 15, 2021 and Mar 6, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 6, 2026Detachment of Device or Device Component

  AS REPORTED, A 5F 125 CM TEMPO DIAGNOSTIC CATHETER BROKE OFF AT THE HUB DURING EXTRACTION FROM THE SHEATH. THE SEPARATED SEGMENT WAS BROKEN OFF IN THE PATIENT¿S BODY BUT WAS SUCCESSFULLY RETRIEVED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532053 ↗
• MalfunctionJun 24, 2024Degraded; Material Puncture/Hole; Degraded; Material Puncture/Hole

  AS REPORTED, FOUR 5F SIDEWINDER II TEMPO 0.038 125CM DIAGNOSTIC CATHETERS WERE FOUND TO BE CUT AT ANGULATION WITH RISK OF DETACHMENT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 5F TEMPO 0.038 125CM DIAGNOSTIC CATHETER OF A DIFFERENT LOT NUMBER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE MEANT TO BE USED IN THROMBECTOMY PROCEDURES. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE FOUR DEVICES USED WILL BE RETURNED FOR EVALUATION AS WELL AS ONE STERILE DEVICE AND ONE DEVICE THAT WAS OPENED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594120 ↗
• MalfunctionJun 24, 2024Degraded; Material Puncture/Hole; Degraded; Material Puncture/Hole

  AS REPORTED, FOUR 5F SIDEWINDER II TEMPO 0.038 125CM DIAGNOSTIC CATHETERS WERE FOUND TO BE CUT AT ANGULATION WITH RISK OF DETACHMENT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 5F TEMPO 0.038 125CM DIAGNOSTIC CATHETER OF A DIFFERENT LOT NUMBER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE MEANT TO BE USED IN THROMBECTOMY PROCEDURES. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE FOUR DEVICES USED WILL BE RETURNED FOR EVALUATION AS WELL AS ONE STERILE DEVICE AND ONE DEVICE THAT WAS OPENED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594095 ↗
• MalfunctionJun 24, 2024Degraded; Material Puncture/Hole; Degraded; Material Puncture/Hole

  AS REPORTED, FOUR 5F SIDEWINDER II TEMPO 0.038 125CM DIAGNOSTIC CATHETERS WERE FOUND TO BE CUT AT ANGULATION WITH RISK OF DETACHMENT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 5F TEMPO 0.038 125CM DIAGNOSTIC CATHETER OF A DIFFERENT LOT NUMBER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE MEANT TO BE USED IN THROMBECTOMY PROCEDURES. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE FOUR DEVICES USED WILL BE RETURNED FOR EVALUATION AS WELL AS ONE STERILE DEVICE AND ONE DEVICE THAT WAS OPENED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594076 ↗
• MalfunctionJan 17, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN OPENING FOUR (4) 5F TEMPO 0.038 125CM GUIDING CATHETERS WERE FOUND BROKEN DISTALLY (CURVATURE) AND PROXIMALLY. THE DEVICES COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTICED DURING THE PROCEDURE. THE SHAPE OF THE BODY/SHAFT WAS DESCRIBED AS "LIKE TURTLE OR FISH SCALES AT THE SHAPE"(TINY PIECES CRACKED BUT STILL ATTACHED TO ONE POINT ON THE CATHETER). THE BRAIDED CORE WIRE WAS NOT EXPOSED AND IT IS UNKNOWN IF THE CATHETERS WERE DELAMINATED OR COMPRESSED CRUSHED AS IT WAS FURTHER CLARIFIED. THE PRODUCTS WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGES OR DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN CORDIS DEVICE WITH A DIFFERENT SHAPE. ALL 4 DEVICES WERE DISCARDED AT SITE AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION. PICTURES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531157 ↗
• MalfunctionJan 17, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN OPENING FOUR (4) 5F TEMPO 0.038 125CM GUIDING CATHETERS WERE FOUND BROKEN DISTALLY (CURVATURE) AND PROXIMALLY. THE DEVICES COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTICED DURING THE PROCEDURE. THE SHAPE OF THE BODY/SHAFT WAS DESCRIBED AS "LIKE TURTLE OR FISH SCALES AT THE SHAPE"(TINY PIECES CRACKED BUT STILL ATTACHED TO ONE POINT ON THE CATHETER). THE BRAIDED CORE WIRE WAS NOT EXPOSED AND IT IS UNKNOWN IF THE CATHETERS WERE DELAMINATED OR COMPRESSED CRUSHED AS IT WAS FURTHER CLARIFIED. THE PRODUCTS WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGES OR DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN CORDIS DEVICE WITH A DIFFERENT SHAPE. ALL 4 DEVICES WERE DISCARDED AT SITE AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION. PICTURES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18529518 ↗
• MalfunctionJan 17, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN OPENING FOUR (4) 5F TEMPO 0.038 125CM GUIDING CATHETERS WERE FOUND BROKEN DISTALLY (CURVATURE) AND PROXIMALLY. THE DEVICES COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTICED DURING THE PROCEDURE. THE SHAPE OF THE BODY/SHAFT WAS DESCRIBED AS "LIKE TURTLE OR FISH SCALES AT THE SHAPE"(TINY PIECES CRACKED BUT STILL ATTACHED TO ONE POINT ON THE CATHETER). THE BRAIDED CORE WIRE WAS NOT EXPOSED AND IT IS UNKNOWN IF THE CATHETERS WERE DELAMINATED OR COMPRESSED CRUSHED AS IT WAS FURTHER CLARIFIED. THE PRODUCTS WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGES OR DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN CORDIS DEVICE WITH A DIFFERENT SHAPE. ALL 4 DEVICES WERE DISCARDED AT SITE AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION. PICTURES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18529191 ↗
• MalfunctionJan 17, 2024Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN OPENING FOUR (4) 5F TEMPO 0.038 125CM GUIDING CATHETERS WERE FOUND BROKEN DISTALLY (CURVATURE) AND PROXIMALLY. THE DEVICES COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE DAMAGE WAS NOTICED DURING THE PROCEDURE. THE SHAPE OF THE BODY/SHAFT WAS DESCRIBED AS "LIKE TURTLE OR FISH SCALES AT THE SHAPE"(TINY PIECES CRACKED BUT STILL ATTACHED TO ONE POINT ON THE CATHETER). THE BRAIDED CORE WIRE WAS NOT EXPOSED AND IT IS UNKNOWN IF THE CATHETERS WERE DELAMINATED OR COMPRESSED CRUSHED AS IT WAS FURTHER CLARIFIED. THE PRODUCTS WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGES OR DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN CORDIS DEVICE WITH A DIFFERENT SHAPE. ALL 4 DEVICES WERE DISCARDED AT SITE AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION. PICTURES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528697 ↗
• InjuryMar 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 5F 0.038¿ 125CM II TEMPO DIAGNOSTIC CATHETER BROKE ABOUT 30CM FROM THE HUB DURING A STROKE PROCEDURE. THE DISTAL PART WAS LEFT IN THE AORTIC ARCH WHILE PROCEEDING WITH THE PROCEDURE AND LATER REMOVED FROM THE VESSEL WITH A SNARE. THE CATHETER HAD NOT YET BEEN PLACED IN THE CAROTID ARTERY. IT WAS MENTIONED THAT THIS HAPPENED WHEN THE DOCTOR TURNED THE CATHETER TWICE IN THE ARCH. THE CATHETER WAS INSERTED THROUGH A LONG SHEATH (NON-CORDIS). THE DOCTOR PULLED THE PROXIMAL PART OF THE CATHETER OUT AND CONTINUED THE PROCEDURE VIA THE LEFT GROIN. THE PROCEDURE (STROKE TREATMENT) WAS PERFORMED SUCCESSFULLY. AFTER FINISHING THE PROCEDURE, THE DISTAL PART OF THE CATHETER WAS SUCCESSFULLY CAPTURED WITH A SNARE. THE DEVICE WAS OPENED IN STERILE FIELD. THE LESION HAD MODERATE CALCIFICATION OF AORTIC ARCH. THERE WAS MODERATE VESSEL TORTUOSITY. THERE WAS NO STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. RESISTANCE WAS NOT MET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488238 ↗