CORDIS 502102DRecalls & reported problems
Cordis US Corp. · ACCS CATH EXTEN 100CM 1200PSI · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705032064729), received between Jul 29, 2022 and Sep 28, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (21 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash21
- Detachment of Device or Device Component16
Patient problems
- No Clinical Signs, Symptoms or Conditions37
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924589 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924532 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923832 ↗MalfunctionSep 28, 2026Leak/Splash
As reported, when the 100cm extension tubing was connected to the device and operated, air bubbles formed immediately, rendering the product unusable. There was no reported injury to the patient. The devices were discarded. therefore, the products are not available for return and evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923257 ↗MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923192 ↗MalfunctionSep 28, 2026Leak/Splash
As reported, when the 100cm extension tubing was connected to the device and operated, air bubbles formed immediately, rendering the product unusable. There was no reported injury to the patient. The devices were discarded. therefore, the products are not available for return and evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917194 ↗MalfunctionSep 28, 2026Leak/Splash
As reported, when the 100cm extension tubing was connected to the device and operated, air bubbles formed immediately, rendering the product unusable. There was no reported injury to the patient. The devices were discarded. therefore, the products are not available for return and evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916669 ↗MalfunctionSep 28, 2026Leak/Splash
As reported, when the 100cm extension tubing was connected to the device and operated, air bubbles formed immediately, rendering the product unusable. There was no reported injury to the patient. The devices were discarded. therefore, the products are not available for return and evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916060 ↗MalfunctionSep 25, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899850 ↗MalfunctionSep 15, 2026Leak/Splash
As reported, water leakage and air bubbles occurred immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making the product unusable. The product was also difficult to disconnect from the device. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The device is not being returned because the hospital discarded the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766299 ↗MalfunctionSep 15, 2026Leak/Splash
As reported, water leakage and air bubbles occurred immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making the product unusable. The product was also difficult to disconnect from the device. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The device is not being returned because the hospital discarded the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766289 ↗MalfunctionSep 15, 2026Leak/Splash
As reported, water leakage and air bubbles occurred immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making the product unusable. The product was also difficult to disconnect from the device. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The device is not being returned because the hospital discarded the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766281 ↗MalfunctionSep 15, 2026Leak/Splash
As reported, water leakage and air bubbles occurred immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making the product unusable. The product was also difficult to disconnect from the device. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The device is not being returned because the hospital discarded the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766279 ↗MalfunctionSep 15, 2026Leak/Splash
As reported, water leakage and air bubbles occurred immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making the product unusable. The product was also difficult to disconnect from the device. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The device is not being returned because the hospital discarded the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766266 ↗MalfunctionSep 14, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747989 ↗MalfunctionSep 13, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747437 ↗MalfunctionSep 11, 2026Leak/Splash
As reported, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable. The same defect occurred in all five products. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The procedure was continued using a 1200 mm Braid Tubing Line. All defective products were discarded and were not retained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725732 ↗MalfunctionSep 11, 2026Leak/Splash
As reported, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable. The same defect occurred in all five products. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The procedure was continued using a 1200 mm Braid Tubing Line. All defective products were discarded and were not retained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725721 ↗MalfunctionSep 11, 2026Leak/Splash
As reported, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable. The same defect occurred in all five products. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The procedure was continued using a 1200 mm Braid Tubing Line. All defective products were discarded and were not retained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725705 ↗MalfunctionSep 11, 2026Leak/Splash
As reported, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable. The same defect occurred in all five products. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The procedure was continued using a 1200 mm Braid Tubing Line. All defective products were discarded and were not retained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725680 ↗MalfunctionSep 11, 2026Leak/Splash
As reported, air bubbles formed immediately when a 100cm 1200psi angiographic catheter extension was connected to the device and operated, making it unusable. The same defect occurred in all five products. There was no reported patient injury. The device was not torqued against resistance while connecting to the tubing, and no difficulty was encountered while attempting to connect to a concomitant device. The procedure was continued using a 1200 mm Braid Tubing Line. All defective products were discarded and were not retained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725658 ↗MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
HOLD FOR TG 10.14AS REPORTED, THE PLASTIC TUBE OF TWO 100 CM EXTENSION CATHETERS WHICH IS INSIDE THE METAL PART WAS SEPARATED DURING THE CONNECTION TO ANOTHER DEVICE, THE RETAINER TUBING SEPARATED IN TWO EXTENSION CATHETERS. THE EXTENSION TUBING BROKE WHEN IT WAS INITIALLY USED. THE PROCEDURE WAS COMPLETED WITH A THIRD EXTENSION CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EXTENSION CATHETER WAS STORED, HANDLED, AND PREPPED BY THE INSTRUCTIONS FOR USE (IFU). THE INTENDED TARGET LESION WAS THE DESCENDING AORTA. THE EXTENSION CATHETER WAS USED IN A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) CASE. A NON-CORDIS POWER INJECTOR WAS USED, AND PSI WAS 900. THE DEVICE WAS NOT KINKED AROUND SEPARATION. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15546576 ↗MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE PLASTIC TUBE OF TWO 100 CM EXTENSION CATHETERS WHICH IS INSIDE THE METAL PART WAS SEPARATED DURING THE CONNECTION TO ANOTHER DEVICE, THE RETAINER TUBING SEPARATED IN TWO EXTENSION CATHETERS. THE EXTENSION TUBING BROKE WHEN IT WAS INITIALLY USED. THE PROCEDURE WAS COMPLETED WITH A THIRD EXTENSION CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EXTENSION CATHETER WAS STORED, HANDLED, AND PREPPED BY THE INSTRUCTIONS FOR USE (IFU). THE INTENDED TARGET LESION WAS THE DESCENDING AORTA. THE EXTENSION CATHETER WAS USED IN A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) CASE. A NON-CORDIS POWER INJECTOR WAS USED, AND PSI WAS 900. THE DEVICE WAS NOT KINKED AROUND SEPARATION. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15546481 ↗MalfunctionAug 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, "THE TIP" OF A 100 CM EXTENSION CATHETER CAME OUT FROM PATIENT'S VASCULAR SEPARATED. THE SEPARATION OCCURRED WHEN RETRACTING THE EXTENSION AFTER USING INJECTOR, THE CATHETER EXTENSION PART WAS CAUGHT IN THE HUB AND SEPARATED. ANOTHER UNKNOWN EXTENSION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EXTENSION CATHETER WAS USED IN A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CASE. THE INTENDED TARGET LESION WAS THE LEFT CORONARY ARTERY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS PER USE (IFU). THE DEVICE DID NOT KINK AROUND SEPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15161099 ↗MalfunctionAug 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE TIP OF A 100 CM EXTENSION CATHETER CAME OUT FROM PATIENT'S VASCULAR SEPARATED. THE SEPARATION OCCURRED WHEN RETRACTING THE EXTENSION AFTER USING INJECTOR, THE CATHETER EXTENSION PART WAS CAUGHT IN THE HUB AND SEPARATED. ANOTHER UNKNOWN EXTENSION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EXTENSION CATHETER WAS USED IN A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CASE. THE INTENDED TARGET LESION WAS THE RIGHT CORONARY ARTERY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS PER USE (IFU). THE DEVICE DID NOT KINK AROUND SEPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15161098 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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