Retracta G34189Recalls & reported problems
Cook Incorporated · Retracta Detachable Embolization Coil · Class 2 · Implant
All models of Retracta (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002341897), received between Jan 17, 2017 and Oct 9, 2023 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Failure6
- Difficult or Delayed Separation3
- Break2
- Material Separation2
- Activation, Positioning or Separation Problem1
- Premature Separation1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2023Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17900851 ↗MalfunctionSep 28, 2023Break; Material Separation; Difficult or Delayed Separation; Break; Material Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL SEPARATED DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTS (TIPS) ON A 59-YEAR-OLD FEMALE PATIENT. DURING THE PROCEDURE, A VASCULAR PLUG FROM ANOTHER MANUFACTURER WAS PLACED INTO THE 6MM TARGET VESSEL AND FLOW WAS ASSESSED AFTER WAITING FOR A MINUTE. AS THERE WAS STILL FLOW PRESENT, 7-8 RETRACTA COILS WERE IMPLANTED; HOWEVER, FLOW CONTINUED. AN ATTEMPT TO PLACE AN ADDITIONAL RETRACTA COIL (RPN: MWCER-35-7-8, LOT: 15248800) WAS MADE. BUT THE COIL DID NOT DETACH COMPLETELY AND BECAME SEPARATED. THE USER NOTED A SECTION OF SEPARATED COIL STILL ATTACHED TO THE DELIVERY WIRE UPON REMOVAL. NO ADDITIONAL INTERVENTIONS TO REMOVE THE SEPARATED COIL WERE NEEDED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO OTHER PRODUCTS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839616 ↗MalfunctionApr 11, 2023Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16717870 ↗InjuryMar 24, 2023Material Separation; Material Separation
IT WAS REPORTED THERE WAS AN INCIDENT INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL DURING A SPLENIC EMBOLIZATION OF AN UNKNOWN PATIENT. WHEN TURNING TO DETACH THE COIL, THE DELIVERY WIRE SEPARATED. THE SEPARATED PIECE OF DELIVERY WIRE COULD NOT BE REMOVED AND REMAINED IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 16614218 ↗MalfunctionJan 29, 2021Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11250236 ↗MalfunctionJan 6, 2021Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11127612 ↗MalfunctionJan 6, 2021Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11127117 ↗MalfunctionJan 5, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED SEVERAL RETRACTA DETACHABLE EMBOLIZATION COILS FOR A PERCUTANEOUS PORTAL VEIN EMBOLIZATION PROCEDURE. THE JUNCTION ZONE OF THE DELIVERY WIRE WAS CORRECTLY POSITIONED AND THE TORQUE DEPLOYMENT DEVICE WAS UTILIZED FOR EACH COIL. ALL OF THE COILS EVENTUALLY DEPLOYED, BUT SOME REQUIRED PROLONGED ROTATION OF THE DELIVERY WIRE. THE FOLLOWING PROVIDES INFORMATION REGARDING ALL THE COILS UTILIZED DURING THE PROCEDURE AND THEIR CORRESPONDING REPORTS. IT IS UNCLEAR WHICH AND HOW MANY COILS EXPERIENCED THE DIFFICULTY DEPLOYING. REPORTED UNDER MANUFACTURER REFERENCE NUMBER 256960 MWCER-35-7-14, LOT# 8263748, QUANTITY: 1REPORTED UNDER MANUFACTURER REFERENCE NUMBER 256985 MWCER-35-7-16, LOT# 8045851, QUANTITY: 2. REPORTED UNDER MANUFACTURER REFERENCE NUMBER 256986 MWCER-35-7-8, LOT# 8302034, QUANTITY: 1. REPORTED UNDER MANUFACTURER REFERENCE NUMBER 256987 MWCER-35-7-8, LOT# 7264121, QUANTITY: 1. REPORTED UNDER MANUFACTURER REFERENCE NUMBER 256990 MWCER-35-14-14, LOT# 7829902, QUANTITY 1. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11120332 ↗MalfunctionJan 5, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11119924 ↗MalfunctionDec 31, 2020Separation Failure; Separation Failure
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11100325 ↗MalfunctionMar 18, 2020Stretched; Premature Separation; Stretched; Premature Separation
EXAMINATION OF THE PRODUCT RETURNED ON 31MAR2020 SHOWED ELONGATION OF THE COIL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9848938 ↗MalfunctionSep 19, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 19SEP2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9088024 ↗InjuryJan 17, 2017Break; Break
THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT AN EMBOLIZATION ( BELLY) PROCEDURE. THE EMBOLIZATION COIL FAILED TO RELEASE FROM THE DELIVERY WIRE AS REQUIRED. THE ATTENDING PHYSICIAN ATTEMPTED TO RELEASE THE COIL BY TURNING THE WIRE/ DEVICE COUNTER-CLOCKWISE (ANTI-CLOCKWISE.) THE DELIVERY WIRE FRACTURED; THE ATTENDING LEFT THE EMBOLIZATION COIL WITH A FRAGMENT OF THE DELIVERY WIRE IN-SITU, THE SPECIFIC ANATOMICAL SITE WAS NOT PROVIDED. A SECTION APPROXIMATELY 1 CM OF THE DEVICE REMAINS WITHIN THE PATIENTS' BODY. NO FURTHER PATIENT EVENT DETAILS WERE PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 6256143 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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