Formula 418Recalls & reported problems across all models
Cook Incorporated · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 12 models of Formula 418 by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2018 and Oct 25, 2024 — classified as 8 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (13 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 Formula 418 problems
Device problems
- Premature Separation13
- Material Rupture3
- Difficult to Remove2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Device Slipped1
- Failure to Advance1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient9
- No Code Available5
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient3
- Bradycardia1
- Foreign Body In Patient1
- Low Blood Pressure/ Hypotension1
Formula 418 models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Formula 418 G56611STENT, RENAL7 reports
- Formula 418 G42973CATHETER, BILIARY, DIAGNOSTIC5 reports
- Formula 418 G42970CATHETER, BILIARY, DIAGNOSTIC1 report
- Formula 418 G42971CATHETER, BILIARY, DIAGNOSTIC1 report
- Formula 418 G56609STENT, RENAL1 report
- Formula 418 G56610STENT, RENAL1 report
- Formula 418 G56614STENT, RENAL1 report
- Formula 418 G56618STENT, RENAL1 report
- Formula 418 G56623STENT, RENAL1 report
- Formula 418 G56625STENT, RENAL1 report
- Formula 418 G56626STENT, RENAL1 report
- Formula 418 G56627STENT, RENAL1 report
Recent Formula 418 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Premature Separation; Premature Separation
AS REPORTED, DURING A PROCEDURE INVOLVING IMPLANTATION OF A STENT WITHIN THE RENAL ARTERY, A FORMULA 418 RENAL BALLOON-EXPANDABLE STENT SLIPPED OFF THE BALLOON. THE DEVICE WAS LOADED THROUGH ANOTHER MANUFACTURER¿S 6-FRENCH GUIDE AND ADVANCED NEAR THE RENAL ARTERY. THE INSERTION TOOL WAS NOT USED TO INSERT THE DEVICE INTO THE GUIDE/SHEATH; HOWEVER, A LARGE TUOHY-BORST ADAPTER WAS USED DURING INSERTION. THE STENT WAS NOT MOISTENED WITH HEPARINIZED SALINE AND GAUZE WAS NOT USED TO MOISTEN THE STENT. THE REFERENCE VESSEL DIAMETER WAS APPROXIMATELY SIX MILLIMETERS, AND THE LESION WAS LESS THAN FIVE CENTIMETERS LONG. THE ANATOMY WAS TORTUOUS, AND THE LESION WAS CALCIFIED AND NINETY PERCENT STENOSED. AS THE USER ATTEMPTED TO MANEUVER THE STENT THROUGH THE STENOSED LESION, THE STENT SLIPPED OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO QUICKLY CAPTURE AND RETRIEVE THE STENT USING ANOTHER MANUFACTURER¿S BALLOON, AND THE STENT WAS THEN DEPLOYED AND IMPLANTED IN THE RENAL ARTERY AS INTENDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537816 ↗MalfunctionJan 2, 2024Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED 03JAN2024. THE ANATOMY WAS STENOSED AND CALCIFIED, AND THE LESION WAS NINETY-PERCENT OCCLUDED. THE LESION WAS BALLOONED WITH A COOK ANGIOPLASTY BALLOON PRIOR TO USE OF THE COMPLAINT DEVICE. THE ANGIOPLASTY BALLOON WAS REMOVED INTACT. NEGATIVE PRESSURE WAS MAINTAINED UPON REMOVAL OF THE COMPLAINT DEVICE, WHICH WAS REMOVED INTACT WITH AN UNSPECIFIED COOK 6-FRENCH SHEATH, AS THE COMPLAINT DEVICE WAS STUCK IN THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18428380 ↗InjurySep 5, 2023Premature Separation; Premature 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 17686249 ↗MalfunctionMay 6, 2022Premature Separation; Premature Separation
AS REPORTED, A FORMULA 418 RENAL BALLOON-EXPANDABLE STENT DETACHED FROM THE BALLOON. THE ACCESS SITE WAS THE RIGHT FEMORAL VEIN (RFV) AND THE TARGET SITE WAS THE LEFT PULMONARY ARTERY (LPA). THE BALLOON AND STENT WERE INSERTED THROUGH A 5 FRENCH COOK SHEATH (WITHOUT ROTATING) AND UPON EXITING THE SHEATH WITHIN THE INFERIOR VENA CAVA, THE USER NOTICED THAT THE STENT WAS NOT CENTERED ON THE BALLOON. THE USER THEN REMOVED THE BALLOON CATHETER THROUGH THE SHEATH. HOWEVER; THE STENT CAME OFF THE BALLOON AND BECAME STUCK IN THE SHEATH DURING REMOVAL. THE SHEATH AND STENT WERE REMOVED AND REPLACED WITH A NEW SHEATH AND STENT TO CONTINUE THE PROCEDURE. THE ANATOMY WAS NOT TORTUOUS AND THE BALLOON WAS NEVER INFLATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14310664 ↗InjuryMay 5, 2021Difficult to Remove; Difficult to Remove
AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT WITHIN THE ILIAC ARTERY, A FORMULA 418 BILIARY BALLOON EXPANDABLE STENT BECAME STUCK IN THE PATIENT. THE WIRE GUIDE LUMEN WAS FLUSHED, AND A WIRE WAS PLACED ACROSS THE LESION. IT IS UNKNOWN IF THE STENT WAS MOISTENED WITH HEPARINIZED SALINE. THE INSERTION TOOL WAS NOT USED, NOR WAS A TUOHY-BORST ADAPTER. THE USER WAS ATTEMPTING TO PLACE THE BILIARY STENT IN THE ILIAC ARTERY USING AN UNKNOWN INFLATION DEVICE; HOWEVER, IT WOULD NOT EXPAND AND WAS UNABLE TO BE REMOVED FROM AN UNKNOWN 7 FRENCH SHEATH. VESSEL SPASMS WERE NOT NOTED. THE STENT REMAINED ON THE DEPLOYMENT SYSTEM, AND THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL FOR SURGICAL REMOVAL. THE UNDEPLOYED STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT, WHO IS REPORTEDLY DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11776713 ↗MalfunctionNov 25, 2020Premature 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 Consequences Or Impact To Patient
MAUDE report 10906053 ↗MalfunctionOct 21, 2020Premature Separation; Premature Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10710433 ↗InjuryAug 14, 2020Premature Separation; Premature Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Code Available
MAUDE report 10407022 ↗MalfunctionAug 11, 2020Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Remove; Stretched; Detachment of Device or Device Component
UPON RETURN OF THE COMPLAINT DEVICE, AN UNSPECIFIED COOK FLEXOR SHEATH WAS ALSO RETURNED AND WAS NOTED TO BE SEPARATED. THE SEPARATED SHEATH WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6). NO OTHER INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10390724 ↗MalfunctionMar 18, 2020Premature Separation; Premature Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 3/25/2020 NOTING THAT THE DEVICE HAD NOT ENTERED THE SHEATH. ACCORDING TO THE INITIAL REPORTER, THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY. MODERATE CALCIFICATION AND TORTUOSITY WERE NOTED. THE STENT CAME OFF THE DISTAL TIP OF THE BALLOON BEFORE THE DEVICE ENTERED THE PATIENT, CONSEQUENTLY, NO INSERTION TOOL WAS USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9847962 ↗InjuryMar 16, 2020Material Rupture; Material Separation; Material Rupture; Material Separation
ADDITIONAL INFORMATION RECEIVED 20MAR2020. THE STENT WAS SUCCESSFULLY PLACED. THE MARKER BAND REMAINED IN PLACE.
Patient problems: No Code Available
MAUDE report 9835164 ↗MalfunctionMar 13, 2020Premature 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 Known Impact Or Consequence To Patient
MAUDE report 9831396 ↗MalfunctionFeb 20, 2020Premature Separation; Premature Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732390 ↗InjuryFeb 20, 2020Premature Separation; Premature Separation
ADDITIONAL INFORMATION RECEIVED 11JUN2020. THE DEVICES WERE USED TO ATTEMPT TO STENT A RIGHT-VENTRICLE-TO-PULMONARY-ARTERY CONDUIT PREVIOUSLY CREATED IN A NORWOOD OPERATION DUE TO A HISTORY OF HYPOPLASTIC LEFT HEART SYNDROME.
Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; No Consequences Or Impact To Patient
MAUDE report 9732368 ↗MalfunctionFeb 17, 2020Premature Separation; Premature Separation
ADDITIONAL INFORMATION RECEIVED 19MAR2020. THE INSERTION TOOL WAS NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9716658 ↗
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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