RetractaRecalls & reported problems across all models
Cook Incorporated · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 160
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 15 models of Retracta by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2014 and Apr 30, 2026 — classified as 32 injuries, 128 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Retracta problems
Device problems
- Separation Failure46
- Difficult or Delayed Separation36
- Material Separation21
- Unraveled Material16
- Premature Separation15
- Stretched14
- Break9
- Failure to Advance8
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Consequences Or Impact To Patient36
- No Known Impact Or Consequence To Patient32
- Foreign Body In Patient14
- Device Embedded In Tissue or Plaque8
- Insufficient Information8
- No Code Available6
- Abdominal Pain3
Retracta models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Retracta G34200Device, Vascular, for Promoting Embolization27 reports
- Retracta G34199Device, Vascular, for Promoting Embolization19 reports
- Retracta G34201Device, Vascular, for Promoting Embolization19 reports
- Retracta G34198Device, Vascular, for Promoting Embolization17 reports
- Retracta G34189Device, Vascular, for Promoting Embolization13 reports
- Retracta G34188Device, Vascular, for Promoting Embolization12 reports
- Retracta G34197Device, Vascular, for Promoting Embolization12 reports
- Retracta G34202Device, Vascular, for Promoting Embolization11 reports
- Retracta G34204Device, Vascular, for Promoting Embolization8 reports
- Retracta G34190Device, Vascular, for Promoting Embolization7 reports
- Retracta G34203Device, Vascular, for Promoting Embolization6 reports
- Retracta G34187Device, Vascular, for Promoting Embolization4 reports
- Retracta G34191Device, Vascular, for Promoting Embolization2 reports
- Retracta G34192Device, Vascular, for Promoting Embolization2 reports
- Retracta G34193Device, Vascular, for Promoting Embolization1 report
Recent Retracta adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Difficult or Delayed Separation
THE FOLLOWING EVENT REGARDING RETRACTA DETACHABLE EMBOLIZATION COILS WAS REPORTED VIE THE LITERATURE ARTICLE: NASSAR, M.; HOLT, M.; AFIFI, A.M.; NAZZAL, M. AN UNCOMMON COMPLICATION OF COIL EMBOLIZATION: COIL DEPLOYMENT SYSTEM MALFUNCTION LEADING TO RETAINED INTRA-AORTIC WIRE. J. VASC. SURG. CASES INNOV. TECH. 2026, 12, HTTPS://DOI.ORG/10.1016/J.JVSCIT.2026.102155. CASE REPORT "A 52-YEAR-OLD WOMAN WITH A PAST MEDICAL HISTORY OF NOONAN SYNDROME AND HYPERLIPIDEMIA WHO WAS ADMITTED OWING TO LETHARGY AND ACUTE KIDNEY INJURY. NOONAN SYNDROME IS A GENETIC DISORDER THAT IS ASSOCIATED WITH SHORT STATURE, CHARACTERISTIC FACIES, AND HEART DEFECTS; SOME PATIENTS HAVE COAGULATION DEFECTS. THE PATIENT SUBSEQUENTLY DEVELOPED SHORTNESS OF BREATH AND MELENA, WHICH WAS ATTRIBUTED TO UPPER GI BLEEDING. IN ADDITION, SHE WAS FOUND TO HAVE SUBMASSIVE PULMONARY EMBOLISM WITH RIGHT HEART STRAIN. IT IS UNCLEAR WHETHER THERE WAS A CONTRIBUTION OF THE PATIENT¿S HISTORY OF NOONAN SYN-DROME TO HER COAGULOPATHY, BUT IT DOES RAISE SUSPICION. THE PATIENT WAS TAKEN TO THE ENDOVASCULAR SUITE FOR ENDOSCOPIC EVALUATION AND INTERVENTION FOR THE GI BLEED AND CATHETER-DIRECTED MECHANICAL THROMBECTOMY OF THE PULMONARY AR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046317 ↗MalfunctionJan 23, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION REPORTED ON 28JAN2025 AND 29JAN205, IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTED TO THE DEVICE UPON OPENING THE PACKAGE. A COIL EMBOLIZATION DURING EVAR PROCEDURE WAS BEING COMPLETED AT THE TIME OF FAILURE AND TREATMENT SITE WAS WITHIN THE INTERNAL ILIAC. IMA EMBOLIZATION WAS ANOTHER EMBOLIC TREATMENT USED. IT WAS CONFIRMED THAT THE PHYSICIAN FLUSHED THE CATHETER PRIOR TO EACH COIL DEPLOYMENT. THE DEPLOYED COILS REMAINED IN THE TARGET VESSEL AND WERE NOT RETRIEVED. THEY WERE NOT STRETCHED OR COMPRESSED. THERE WAS NO DIFFICULTY ADVANCING THE PUSHER STYLET THROUGH THE SHIPPING CARTRIDGE. IT WAS CONFIRMED THAT THERE WAS DIFFICULTY DETACHING THE COIL FROM THE DELIVERY WIRE. THE COIL WAS REPOSITIONED ABOUT 2 TIMES. DIFFICULTY WAS EXPERIENCED WHEN RETRACTING THE WIRE/COIL, WITH THE COIL BEING UNABLE TO DETACH SUCCESSFULLY. AROUND 10 CLOCKWISE AND COUNTERCLOCKWISE TURNS WERE USED TO DETACH THE COIL. THE JUNCTION ZONE WAS JUST INSIDE THE TIP OF THE CATHETER DURING DEPLOYMENT AND WAS NOT DAMAGED THE PATIENT WAS NOT ON ANY ANTICOAGULATION MEDICATION. NO ALLERGIC REACTIONS OR ADVERSE EFFECTS WERE EXPERIENCED DUE TO THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21225761 ↗MalfunctionJan 21, 2025Difficult 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 Clinical Signs, Symptoms or Conditions
MAUDE report 21200657 ↗MalfunctionJan 20, 2025Break; Unraveled Material; Break; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED ON 21JAN2025: THE CUSTOMER NOTED THAT THERE WAS NO DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. A PUSHER STYLET WAS UTILIZED FOR COIL DEPLOYMENT AND WAS ADVANCED THROUGH THE SHIPPING CARTRIDGE WITHOUT DIFFICULTY. THERE WAS AN ANEURYSM IN THE RIGHT COMMON ILIAC ARTERY. IT WAS CONFIRMED THAT THERE WAS DIFFICULTY DETACHING THE COIL FROM THE DELIVERY WIRE, THE COIL WAS REPOSITIONED 2-3 TIMES. THERE WAS DIFFICULTY IN RETRACTING THE WIRE/COIL AS IT BECAME STUCK IN THE CATHETER. THE COIL DID NOT REMAIN IN THE TARGET VESSEL, AS IT WAS REMOVED ALONG WITH THE CATHETER, THE COIL WAS FOUND TO BE STRETCHED AND BROKE DURING REMOVAL. THE COIL WAS ROTATED BOTH CLOCKWISE AND COUNTERCLOCKWISE, RESULTING IN ITS FAILURE TO DEPLOY. THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, AND THE PATIENT WAS ON EMBOLIC TREATMENT FOR IMA (INFERIOR MESENTERIC ARTERY) EMBOLIZATION. THE PHYSICIAN FLUSHED THE CATHETER BEFORE EACH ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21194163 ↗MalfunctionJan 20, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE DELIVERY WIRE INCLUDED IN RETRACTA DETACHABLE EMBOLIZATION COIL UNRAVELED DURING A COIL EMBOLIZATION PROCEDURE FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN A PATIENT OF UNKNOWN AGE AND GENDER. THE CUSTOMER NOTED THAT THERE WAS NO DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. A PUSHER STYLET WAS UTILIZED FOR COIL DEPLOYMENT AND WAS ADVANCED THROUGH THE SHIPPING CARTRIDGE WITHOUT DIFFICULTY. THE COIL WAS INTRODUCED VIA A TORTUOUS INTERNAL ILIAC ARTERY. IT WAS CONFIRMED THAT THERE WAS DIFFICULTY DETACHING THE COIL FROM THE DELIVERY WIRE, THE COIL WAS REPOSITIONED 2-3 TIMES. THERE WAS DIFFICULTY IN RETRACTING THE WIRE/COIL AS IT BECAME STUCK IN THE CATHETER. THE COIL DID NOT REMAIN IN THE TARGET VESSEL, AS IT WAS REMOVED ALONG WITH THE CATHETER AND WAS FOUND TO BE STRETCHED. THE COIL WAS ROTATED BOTH CLOCKWISE AND COUNTERCLOCKWISE, RESULTING IN ITS FAILURE TO DEPLOY. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, AND NO ADDITIONAL EMBOLIC TREATMENT METHODS WERE USED DURING TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193279 ↗MalfunctionJan 20, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION PROVIDED ON 23JAN2025, IT WAS REPORTED THAT THE JUNCTION ZONE WAS LOCATED JUST OUTSIDE OF THE CATHETER TIP DURING CATHETER DEPLOYMENT. THE USER STATED THAT WHEN DEPLOYING THE COIL, THE DELIVERY WIRE WAS ROTATED 10 TIMES COUNTERCLOCKWISE BUT MAY HAVE BEEN ROTATED CLOCKWISE A FEW TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193275 ↗MalfunctionJan 2, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL HAD "COME OFF" THE CATHETER. THE PHYSICIAN USED ANOTHER DEVICE TO COMPETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057825 ↗MalfunctionDec 5, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IN ADDITIONAL INFORMATION RECEIVED ON 03DEC2024, IT WAS REPORTED THAT THE JUNCTION ZONE WAS LOCATED OUTSIDE OF THE CATHETER DURING DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854304 ↗InjuryNov 26, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 20786227 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT RETRACTA DETACHABLE EMBOLIZATION COIL SEPARATED DURING A COIL EMBOLIZATION PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE CUSTOMER NOTED THAT THERE WAS NO DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. A DEDICATED PUSHER WAS UTILIZED FOR COIL DEPLOYMENT AND WAS ADVANCED THROUGH THE SHIPPING CARTRIDGE WITHOUT DIFFICULTY. THERE WERE NO ROTATIONS MADE DURING ADVANCEMENT INTO THE DELIVERY SITE. THE COIL WAS INTRODUCED VIA FEMORAL ARTERY (FA) AND GUIDED TO THE INTENDED LOCATION IN THE INTERNAL ILIAC ARTERY (IIA). IT WAS NOTED THAT HALF OF THE COIL REACHED THE TARGET AREA AND WAS FOUND TO BE STRETCHED. DURING THE IMPLANTATION PROCESS, THE COIL WAS ROTATED COUNTERCLOCKWISE BEYOND THE RECOMMENDED NUMBER OF ROTATIONS, RESULTING IN ITS FAILURE TO DEPLOY. UPON GENTLE TRACTION, THE COIL BROKE OFF INTO TWO PIECES, WITH ONE PORTION PARTIALLY RETRACTED INTO THE DELIVERY SYSTEM AND THE OTHER PORTION REMAINING IN THE INTENDED DEPLOYMENT LOCATION WITHIN THE PATIENT. THE CATHETER REMAINED INTACT, AND LABELING APPEARED UNAFFECTED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED BY USING COMPETITOR¿S DEVICE. THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, AND NO ADDITIONAL EMBOLIC TR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736959 ↗MalfunctionOct 22, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL FAILED TO DETACH FROM THE DELIVERY WIRE DURING A COIL EMBOLIZATION PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE INTERNAL ILIAC ARTERY WAS APPROACHED FROM THE FEMORAL ARTERY. AFTER THE DEVICE WAS DELIVERED TO THE PLACEMENT SITE, AN ATTEMPT WAS MADE TO DEPLOY THE COIL. THE COIL WAS REPOSITIONED SEVERAL TIMES AND WAS ROTATED COUNTERCLOCKWISE; HOWEVER, THE COIL COULD NOT BE DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER LIKE-DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE CUSTOMER NOTED THAT THE DEVICE WAS UNDAMAGED UPON OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509371 ↗MalfunctionOct 10, 2024Migration; Migration
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20423304 ↗MalfunctionOct 10, 2024Entrapment of Device; Difficult or Delayed Separation; Entrapment of Device; 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 Clinical Signs, Symptoms or Conditions
MAUDE report 20423066 ↗MalfunctionOct 9, 2024Premature Separation; Premature Separation
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 20409681 ↗MalfunctionSep 26, 2024Unraveled Material; Difficult or Delayed Separation; Unraveled Material; Difficult or Delayed Separation
IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL WAS DIFFICULT TO DETACH. THE DEVICE WAS REQUIRED FOR EMBOLIZATION OF A 13MM TORTUOUS RIGHT INTERNAL ILIAC ARTERY (IIA) ANEURYSM DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE DEVICE WAS STORED VERTICALLY. NO DAMAGE TO THE PACKAGING WAS NOTED. DURING THE PROCEDURE, THE COIL WAS ADVANCED FROM THE LEFT FEMORAL ARTERY TO THE TARGET SITE. ONCE THE COIL WAS PLACED AT THE TARGET SITE, THE JUNCTION ZONE WAS POSITIONED JUST OUTSIDE THE CATHETER TIP, AND THE TORQUE DEVICE WAS USED TO TURN THE DELIVERY WIRE 30 TIMES; HOWEVER, THE COIL WOULD NOT DETACH. THE DELIVERY WIRE WAS RETRACTED, AND IT WAS PRESUMED THAT THE COIL HAD DETACHED AND WAS PLACED. THE PROCEDURE CONTINUED "AS USUAL" AND WAS SUCCESSFULLY COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. IT WAS NOTED THE DELIVERY WIRE WILL BE RETURNED TO ENSURE THE COIL DETACHED CORRECTLY. A COMPETITOR¿S COILS WERE ALSO USED DURING THIS PROCEDURE. THE CATHETER WAS NOT FLUSHED BEFORE EACH COIL DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309445 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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