Flexor G44155Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Ansel Modification · Class 2
Quick summary
This Cook Flexor Check-Flo introducer catheter is a guiding sheath used to place catheters and balloons during vascular procedures such as angioplasty. Reports mostly describe the sheath coming apart in the patient — the hub pulling free, the tip splitting or breaking, and material separating or unraveling — with some bleeding at the access site and blood loss. There are 37 reports, including 10 injuries and no deaths. One recall, started in November 2021 and closed, involved packaging where the labeled size did not match the device inside.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00827002441552), received between Apr 17, 2015 and Jul 17, 2025 — classified as 10 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Material Separation” (15 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Nov 12, 2021Terminated
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Z-0388-2022 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Separation15
- Detachment of Device or Device Component10
- Break3
- Material Split, Cut or Torn3
- Unraveled Material3
- Fluid/Blood Leak2
- Peeled/Delaminated2
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient6
- No Code Available5
- Blood Loss2
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Foreign body, removal of1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS INITIALLY REPORTED, DURING AN UNSPECIFIED VASCULAR PROCEDURE, THE ¿FLEXOR ANSEL GUIDING SHEATH¿ BROKE WHILE ADVANCING A COMPETITOR¿S BALLOON THROUGH IT. UPON RECEIVING FURTHER CLARIFICATION, IT WAS CONFIRMED THAT THE HUB SEPARATED FROM THE ¿FLEXOR ANSEL GUIDING SHEATH¿ WHEN THE PHYSICIAN WAS ¿PULLING HARD ON IT¿. CONTRALATERAL ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY. REPORTEDLY, THE PATIENT'S ANATOMY HAD A LOT OF SCAR TISSUE. THE BIFURCATION WAS NORMAL AND NOT CALCIFIED. AN UNSPECIFIED WIRE GUIDE AND A COMPETITOR¿S ANGIOPLASTY BALLOON WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED TO GET THE SHEATH ¿IN AND OUT¿. RESISTANCE WAS ALSO ENCOUNTERED UPON REMOVING THE COMPETITOR¿S ANGIOPLASTY BALLOON UTILIZING THE SHEATH HUB, AND THE HUB SEPARATED. THE DILATOR WAS NOT REINSERTED INTO THE SHEATH PRIOR TO THE REMOVAL OF THE SHEATH. THE SHEATH WAS REMOVED ENDOVASCULARLY FROM THE PATIENT. PER THE REPORTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 'FLEXOR ANSEL GUIDING SHEATH' FROM THE SAME LOT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530105 ↗MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
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 22522705 ↗MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION FOR A CHRONIC TOTAL OCCLUSION, A FLEXOR ANSEL GUIDING SHEATH CAUSED "BLEEDING BACK PROBLEMS." ALTHOUGH ANOTHER MANUFACTURER'S CLOSURE DEVICE WAS DEPLOYED, THE PATIENT EXPERIENCED "MORE BLEEDING" AT THE FEMORAL ARTERIAL ACCESS SITE, REQUIRING PROLONGED MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CLARIFY THE EXACT FAILURE MODE; HOWEVER, CLARIFICATION HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THIS COMPLAINT HAS BEEN REPORTED OUT OF AN ABUNDANCE OF CAUTION FOR A POSSIBLE LEAK IN THE HEMOSTATIC VALVE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20247973 ↗MalfunctionJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
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 18426266 ↗MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 15998462 ↗InjurySep 23, 2022Break; Break
AS REPORTED, IN THE MIDDLE OF A PROCEDURE INVOLVING THE LEFT SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH SEPARATED IN THE PATIENT. THE SHEATH WAS ADVANCED UP AND OVER THE BIFURCATION, OVER AN UNSPECIFIED AMPLATZ WIRE, TO THE LEFT COMMON FEMORAL ARTERY. THE ANATOMY WAS REPORTEDLY VERY CALCIFIED. ANOTHER MANUFACTURER'S BALLOON CATHETER WAS ADVANCED THROUGH THE SHEATH, OVER AN UNKNOWN 0.014-INCH WIRE, AND WAS THEN INFLATED WITHIN A CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE BALLOON WOULD NOT COMPLETELY DEFLATE, AND THE DISTAL FOUR-TO-FIVE CENTIMETERS OF THE BALLOON REMAINED INFLATED AND STUCK IN CALCIFIED LESION. THE BALLOON WAS EVENTUALLY POPPED WITH AN EXTERNAL NEEDLE; HOWEVER, THE BALLOON WAS STILL UNABLE TO BE REMOVED THROUGH THE SHEATH. AFTER MULTIPLE ATTEMPTS TO REMOVE THE BALLOON, THE BALLOON CATHETER SHAFT SEPARATED, LEAVING THE TIP OF THE BALLOON CATHETER IN THE PATIENT. WHILE TRYING TO SNARE THE SEPARATED BALLOON CATHETER AND REMOVE THE SHEATH WITH THE BALLOON CATHETER INSIDE, RESISTANCE WAS ENCOUNTERED AND THE TIP OF THE COMPLAINT DEVICE THEN SEPARATED, LEAVING THE DISTAL PORTION OF
Patient problems: Foreign Body In Patient
MAUDE report 15475015 ↗MalfunctionSep 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, DURING PREPARATION FOR A LEFT LEG ANGIOPLASTY, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH SPLIT. THE DILATOR WAS INSERTED INTO THE SHEATH, AND BOTH THE SHEATH AND DILATOR WERE ATTEMPTED TO BE ADVANCED THROUGH ANOTHER MANUFACTURER'S 7FR SHEATH. THE TIP OF THE SHEATH WAS THEN NOTED TO BE SPLIT, AND A NEW SHEATH WAS OPENED TO CONTINUE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440082 ↗MalfunctionMay 13, 2022Material Separation; Material Separation
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. CONSIDERABLE FORCE WAS NOT APPLIED TO THE HUB AT THE TIME OF THE EVENT. THE SHEATH WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14396720 ↗MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, UPON SUCCESSFUL COMPLETION OF AN ATHERECTOMY PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED AT THE HUB UPON REMOVAL OF THE SHEATH FROM THE PATIENT. ACCESS WAS OBTAINED FROM THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT SUPERFICIAL FEMORAL ARTERY. ANOTHER MANUFACTURER'S WIRE GUIDE, ATHERECTOMY DEVICE, AND UNKNOWN DRUG-COATED BALLOON WERE USED DURING THE PROCEDURE. THE ANATOMY WAS HEAVILY CALCIFIED; HOWEVER, RESISTANCE WAS NOT REPORTED UPON INSERTION OR REMOVAL OF THE DEVICE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL, AND NOTHING WAS IN THE LUMEN OF THE DEVICE AT THE TIME OF HUB SEPARATION. THE HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140858 ↗MalfunctionApr 14, 2022Break; Unraveled Material; Break; Unraveled Material
AS INITIALLY REPORTED, ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE WAS UNABLE TO ADVANCE THROUGH A FLEXOR ANSEL GUIDING SHEATH'S HUB DURING AN ATHERECTOMY PROCEDURE. ANOTHER SHEATH OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHAFT WAS NOTED TO BE SEPARATED BELOW THE HUB AND THE INNER COILS WERE EXPOSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112819 ↗MalfunctionDec 30, 2021Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13119139 ↗MalfunctionSep 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12508537 ↗MalfunctionSep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12414166 ↗MalfunctionAug 3, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 17AUG2021: THE SEPARATION OCCURRED POST-PROCEDURE. THE NURSE WAS PULLING THE SHEATH AND THE HUB SEPARATED. THEY PROCEEDED PULLING THE SHEATH AND NO FURTHER COMPLICATIONS WERE NOTED. NO ADDITIONAL PROCEDURES NEEDED. NO ADDITIONAL DETAILS ARE AVAILABLE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12268762 ↗MalfunctionJun 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11979173 ↗InjuryNov 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Code Available
MAUDE report 10839897 ↗MalfunctionOct 7, 2020Fluid/Blood Leak; Fluid/Blood Leak
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 10644920 ↗MalfunctionOct 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING PLACEMENT OF AN ILIAC STENT, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED. UPON RETURN AND INITIAL INSPECTION OF THE DEVICE, THE HUB WAS NOTED TO BE SEPARATED; HOWEVER, THE DEVICE WAS NOT UNRAVELED. BILATERAL GROIN ACCESS WAS OBTAINED USING UNKNOWN MICROPUNCTURE DEVICES. MINIMAL RESISTANCE WAS REPORTED ON INSERTION AND REMOVAL OF THE COMPLAINT DEVICE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF SEPARATION; HOWEVER, ANOTHER MANUFACTURER'S WIRE GUIDE AND UNKNOWN STENT CATHETER WERE IN THE LUMEN OF THE DEVICE WHEN THE SEPARATION OCCURRED, UPON REMOVAL OF THE STENT CATHETER. VESSEL SPASMS AND BLOOD LOSS WERE NOT REPORTED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10612812 ↗MalfunctionAug 25, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material
IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR INTRODUCER SHEATH & FLEXOR ANSEL GUIDING SHEATH WERE UTILIZED WITH COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER, BOTH DEVICES WERE USED AT THE SAME ACCESS SITE, WHICH WAS NOTED TO HAVE HEAVY CALCIFICATION. WHILE ATTEMPTING TO REMOVE THE OTHER MANUFACTURER'S DEVICE, THE HUB OF ONE OF THE COOK SHEATH'S SEPARATED. DURING THE SAME PROCEDURE, THE OTHER COOK SHEATH UNCOILED; HOWEVER, THE ATTENDING NURSE WAS UNABLE TO IDENTIFIED AT WHAT POINT DURING THE PROCEDURE THIS OCCURRED. ADDITIONALLY, THE INITIAL REPORTER COULD NOT CONFIRM WHAT SHEATH EXHIBITED WHICH FAILURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10450048 ↗MalfunctionFeb 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
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 9720048 ↗InjuryAug 1, 2019Material Separation; Material Separation
ADDITIONAL INFORMATION HAS BEEN RECEIVED NOTING THAT MDR#1820334-2019-01897 AND MDR#1820334-2019-01706 ARE ACTUALLY THE SAME EVENT. THE COMPLAINT FILE ASSOCIATED WITH 01897 HAS BEEN CLOSED/CANCELLED. MOVING FORWARD, ALL ADDITIONAL INFORMATION, AS WELL AS THE INVESTIGATION EVALUATION WILL BE PROVIDED ON 01706.
Patient problems: No Code Available
MAUDE report 8852003 ↗InjuryMay 24, 2019Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8640080 ↗InjuryApr 22, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8536999 ↗MalfunctionJan 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED, THERE WAS DIFFICULTY ADVANCING A FLEXOR ANSEL GUIDING SHEATH INTO THE PATIENT'S LEFT GROIN FOR CONTRALATERAL APPROACH DURING A RIGHT LEG ANGIOGRAM PROCEDURE. WHEN THE PHYSICIAN REMOVED THE COMPLAINT DEVICE FROM THE PATIENT'S ANATOMY, TIP SEPARATION WAS NOTED. THE PHYSICIAN STATED IT FOLDED BACK ON ITSELF. A DILATOR WAS ALSO IN PLACE THROUGH THE SHEATH AT THE TIME OF SEPARATION. THE PATIENT'S ANATOMY WAS CALCIFIED BUT IT IS NOT KNOWN IF IT WAS TORTUOUS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8230735 ↗MalfunctionNov 8, 2018Material Separation; Material Separation
IT WAS REPORTED, AN (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED PERIPHERAL VASCULAR PROCEDURE OF THE FEMORAL ARTERY IN WHICH THE FLEXOR ANSEL GUIDING SHEATH WAS USED. THE PHYSICIAN INSERTED THE SHEATH IN THE GROIN OVER ANOTHER MANUFACTURER'S GUIDEWIRE FOR AN UP AND OVER APPROACH TO TREAT THE CONTRALATERAL SIDE. IT WAS NOTED THAT IT WAS A TIGHT AREA IN THE GROIN AND THE VESSEL WAS CALCIFIED. WHILE RE-ADJUSTING THE DEVICE, THE FLEXOR MATERIAL BROKE AT THE HUB AND SEPARATED. IT WAS NOT A TOTAL SEPARATION. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE PATIENT. ANOTHER SHEATH WAS PLACED AND THERE WERE NO FURTHER ISSUES OR COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES REQUIRED DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8053794 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.