PowerGlide F120080TRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00801741142666), received between Oct 24, 2018 and Feb 18, 2026 — classified as 23 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (23 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Break

  IT WAS REPORTED POWERGLIDE PRO MIDLINE CATHETER 20GUAGE, 8CM TIP BROKEN. THE PATIENT WAS QUICKLY TAKEN TO OR FOR SURGICAL REMOVAL OF THE FOREIGN BODY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24383066 ↗
• InjuryFeb 3, 2026Break

  IT WAS REPORTED THE CATHETER BROKE INSIDE THE PATIENT¿S ARM DURING INSERTION. SHE STATED THAT THIS IS THE ONLY INCIDENT OF THIS KIND AND THAT THE SAME CLINICIAN HAD SUCCESSFULLY INSERTED ANOTHER CATHETER EARLIER THE SAME DAY WITHOUT ANY ISSUES. THE CATHETER WAS REMOVED BY AN INTERVENTIONAL RADIOLOGIST. THERE WERE NO COMPLICATIONS DURING OR FOLLOWING THE PROCEDURE. THE MIDLINE WAS REPLACED IN THE IR DEPARTMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24251497 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY CANNULATED THE VEIN, ADVANCED THE GUIDEWIRE AND THEN HAD DIFFICULTY ADVANCING THE POWERGLIDE CATHETER. UPON FEELING RESISTANCE, WHEN THEY REMOVED THE CATHETER AND NOTED THAT THE CATHETER HAD A BREAKAGE IN THE MIDDLE PORTION OF THE CATHETER.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22980024 ↗
• MalfunctionSep 4, 2025Defective Component; Defective Component

  IT WAS REPORTED BY MEDSUN WHILE INSERTING POWERGLIDE, THE CATHETER SEPARATED FROM THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963484 ↗
• InjuryJul 1, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED 26-JUN-2025: THE PATIENT DID REQUIRE SURGERY TO REMOVE THE BROKEN CATHETER. A NEW MIDLINE WAS PLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22376653 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED VIA MEDWATCH CUSTOMER ATTEMPTED TO PLACE A POWERGLIDE PRO MIDLINE CATHETER AND CATHETER BROKE OFF IN PATIENT. ABLE TO RETRIEVE BROKEN PIECE FROM PATIENT. ADDITIONAL INFORMATION RECEIVED ON 13 JUNE 2025: IT WAS REPORTED WITH THE PIECE BREAKING INSIDE THE PATIENT, THE TEAM HAD TO REMOVE/RETRIEVE THE RETAINED FOREIGN BODY. DID NOT REQUIRE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22358479 ↗
• MalfunctionMay 21, 2025Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  IT WAS REPORTED, UPON INSERTION, NEEDLE WAS HARD TO PIERCE SKIN AND ADVANCE TO VEIN. ONCE VEIN ACCESSED, ADVANCED CATHETER. THEN WHILE REMOVING WIRE I SAW IT COMING OUT THINNER (LIKE SHEARING). REMOVED CATHETER AND WIRE TOGETHER AND SITE HELD TILL HEMOSTASIS ACHIEVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065363 ↗
• InjuryMay 9, 2025Break; Break

  IT WAS REPORTED TRAINEE CLINICIAN SHEERS OFF CATHETER INTO PATIENT AND NOTED THAT UPON PLACEMENT DIFFICULTY WAS NOTED. CLINICIAN STATED TRAINEE TO REMOVE/RETRACT THE MIDLINE OUT OF THE PATIENT'S UPPER EXTREMITY. BOTH REPORTED THAT THE CATHETER WAS FORCIBLY REMOVED AND ATTEMPTED PRIOR TO GUIDEWIRE - THIS ACTION SHEERED THE CATHETER INTO PATIENT SUBCUTANEOUS TISSUE NOT THE VASCULAR SYSTEM. BOTH STATED THAT NEEDLE WAS ADVANCED INSTEAD OF RETRACTING IT. COMMAND WAS TO RETRACT CATHETER SAFETY THEN THE GUIDEWIRE. TRAINEE ERROR OCCURRED DURING THE RETRACTION PROCESS WHICH LED TO SHEERING CATHETER - NEEDLE RETRACTED AND PUSHED FORWARD THEN RETRACTED AGAIN. BOTH CLINICIAN AND TRAINEE STAYED WITH PATIENT, CONTACTED PRIMARY RN, CONTACTED SURGERY. SURGERY ASSESSED AND AGREED WITH CLINICIAN THAT THE CATHETER WAS IN THE SUBCUTANEOUS TISSUE. OR MD STATED IT WAS SAFE TO REMAIN, AND IT WOULD BE REMOVED IN THE AM. CATHETER SEGMENT RETRIEVED AND REMOVED THE MORNING (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 21997531 ↗
• MalfunctionDec 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE POWER GLIDE CATHETER HAD A SMALL PINHOLE LEAK AT THE CATHETER NEAR THE PINK HUB. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021663 ↗
• InjuryNov 19, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT VAT NURSE ATTEMPTED TO PLACE POWERGLIDE IN PATIENT FOR BLOOD SAMPLING AND MEDICATION ADMINISTRATION USING ULTRASOUND GUIDANCE, NEEDLE TIP APPEARED IN CENTER OF VESSEL IN LEFT UPPER ARM. NURSE ATTEMPTED TO ADVANCE THE GUIDEWIRE, WIRE ADVANCED SMOOTHLY. NURSE ATTEMPTED TO ADVANCE THE CATHETER AND MET RESISTANCE, NURSE STOPPED ADVANCING, NO BLOOD RETURN WAS NOTED IN THE CHAMBER, WIRE AND CATHETER UNIT RETRACTED, CATHETER TIP WAS NOT INTACT, PORTION OF CATHETER RETAINED IN PATIENT'S UPPER EXTREMITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20727596 ↗
• MalfunctionSep 19, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT POWERGLIDE WAS PLACED ON A PATIENT., HAD SOME DIFFICULTY THREADING AND WHEN SHE DC'D THE DEVICE, PART OF THE CATHETER BROKE OFF IN THE PATIENT. THE PLACER WAS ABLE TO RETRIEVE THE BROKEN PIECE WITHOUT FURTHER INTERVENTION. ADDITIONAL INFORMATION 08/28/2024: UPON MEETING RESISTANCE, PULLING BACK AND THE CATHETER WAS NOT INTACT SO THEY HAD TO RETRIEVE THE BROKEN PIECE. THE PATIENT WENT THROUGH AN ADDITIONAL STICK AND HAD TO HAVE THE CATHETER PIECE RETRIEVED AT THE BEDSIDE. NO PIECES REMAIN IN THE PATIENT, ALL WERE ACCOUNTED FOR. THERE IS NO IMAGING AVAILABLE FOR THIS INCIDENT. NO SECUREMENT DEVICES WERE USED AS THIS TOOK PLACE DURING PLACEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20256574 ↗
• InjuryAug 7, 2024Break; Break

  IT WAS REPORTED THAT POWERGLIDE BROKE OFF INTO CUSTOMER'S VEIN DURING PLACEMENT. ADDITIONAL INFORMATION RECEIVED JULY 16, 2024: COURSE OF EVENTS: (B)(6) FRACTURED CATHETER UPON INSERTION. VASCULAR SURGEON CONSULTED. 7/11/24 LEFT HUMERUS XRAY DONE. EXPLORATION OF LEFT ARM VEINS BY MD, UNABLE TO LOCATE FRAGMENT OF CATHETER. CVC TRIPLE LUMEN RIGHT: PLACED BY MD (UNABLE TO USE BUE FOR VASCULAR ACCESS: RUE (+) FOR DVT, LUE PRESENCE OF CATHETER FRAGMENT ON BRACHIAL VEINS 7/12/24 CT OF LEFT UPPER EXTREMITY WITHOUT CONTRAST: PRESCENCE OF 1.8 LINEAR HYPODENSITY WHICH COULD REPRESENT CATHETER FRAGMENT WITHIN THE ANTERIOR ARM SOFT TISSUES (B)(6) 2024 EXPLORATION OF LEFT ARM REMOVAL OF CEPHALIC, BASILIC AND BRACHIAL VEIN FROM ANTECUBITAL FOSSAE TO AXILLA ALONG WITH ADJACENT BRANCHES. UNABLE TO LOCATE. (B)(6) 2024 NO FURTHER SURGICAL INTERVENTION. PLACED ON COMFORT CARE MEASURES.

  Patient problems: Foreign Body In Patient

  MAUDE report 19931968 ↗
• InjuryMay 1, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH THAT, "DURING PLACEMENT OF MIDLINE, ACCESSED LEFT CEPHALIC VEIN. UPON ADVANCING THE CATHETER AND RETRACTING THE NEEDLE CATHETER BROKE OFF IN PATIENT'S ARM. PATIENT WAS BROUGHT TO IR AND THE CATHETER FRAGMENT WAS SUCCESSFULLY RETRIEVED BY PHYSICIAN. ORIGINAL MIDLINE DEVICE WAS PLACED IN SHARPS BIN AND IS UNABLE TO BE RETRIEVED. MIDLINE FRAGMENT WAS SAVED AND PLACED IN A STERILE CUP FOR POTENTIAL ANALYSIS." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19222223 ↗
• InjuryApr 8, 2024Break; Break

  IT WAS REPORTED, ON (B)(6) 2024, WHILE OUR NURSE WAS PLACING A MIDLINE ON OUR PATIENT, OUR PATIENT¿S ARM FLINCHED AND INSERTION WAS NOT SUCCESSFUL. NURSE WAS ABLE TO REMOVE THE NEEDLE WITHOUT DIFFICULTY BUT UPON REMOVING THE CATHETER, THERE WAS SOME RESISTANCE. WE CONTACTED ADVANCED ACCESS CONSULTANTS AND THEIR RN CAME OUT TO ASSESS THE CATHETER SITE. AS SHE WAS ATTEMPTING TO ADJUST/REMOVE THE CATHETER, THE CATHETER BROKE, LEAVING 4CM LODGED IN THE PATIENT¿S LUE CEPHALIC SITE. PATIENT WAS SENT TO THE ER TO HAVE IT REMOVED. NURSE WAS SUCCESSFUL WITH MIDLINE INSERTION ON ANOTHER PATIENT, JUST PRIOR TO EXPERIENCING THIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19067634 ↗
• InjuryApr 1, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, "DURING PLACEMENT OF MIDLINE, ACCESSED LEFT CEPHALIC VEIN. UPON ADVANCING THE CATHETER AND RETRACTING THE NEEDLE, CATHETER BROKE OFF INTO PATIENT'S ARM. PATIENT WAS BROUGHT TO IR AND THE CATHETER FRAGMENT WAS SUCCESSFULLY RETRIEVED BY PHYSICIAN. ORIGINAL MIDLINE DEVICE WAS PLACED IN SHARPS BIN AND IS UNABLE TO BE RETRIEVED. NO PATIENT CONCERNS ONCE X-RAY CONFIRMED THEY DID NOT SEE WIRE FRAGMENTS." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19014522 ↗
• MalfunctionFeb 28, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE ISSUES WITH THE ADVANCEMENT. PATIENT NEEDED TO BE STUCK AGAIN AS IT MADE FOR AN UNSUCCESSFUL INSERTION. NO OTHER INFORMATION WAS PROVIDED. 02/15/2024 - THE CATHETER, GUIDEWIRE, AND NEEDLE RETURNED FOR EVALUATION EXHIBITED DEFORMATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18804054 ↗
• InjuryOct 9, 2023Break; Break

  IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTING TO PLACE A POWERGLIDE INTO A PATIENT IN HIS LEFT LOWER FOREARM WHEN RESISTANCE WAS MET. WHEN TRYING TO ADVANCE CATHETER, SOME RESISTANCE WAS ALSO MET WHEN ATTEMPTING TO REMOVE CATHETER AND NEEDLE. NOTED TIP OF CATHETER APPEARED TO BE JAGGED AND SLIGHTLY SHORTER WHEN COMPARED TO SAME SIZE CATHETER. SMALL FIRM PIECE NOTED ON AREA BY THE INSERTION SITE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17894824 ↗
• MalfunctionSep 12, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER THAT EXPERIENCING POOR QUALITY ISSUES WITH THE 20 GAUGE MIDLINE CATHETERS, NO PARTICULAR LOT NUMBER. CATHETERS ARE SAID THE BE HARD TO FLUSH, VERY STIFF AND IF THE CATHETER HAS ANY TYPE OF KINK IT WOULD QUIT WORKING. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFO RECEIVED ON 05-SEP-23. THE EVENT INVOLVED AN URGENT/LIFE THREATENING MEDICAL SITUATION. THE PATIENT SENT TO OR TO HAVE CATHETER REMOVED, AND THIS EVENT CAUSED A DELAY IN PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729662 ↗
• MalfunctionSep 12, 2023Defective Component; Failure to Infuse; Defective Component; Failure to Infuse

  IT WAS REPORTED "WE HAVE ALSO BEEN ADVISED THAT NURSES HAVE BEEN EXPERIENCING POOR QUALITY ISSUES WITH THE 20 GAUGE MIDLINE CATHETERS, NO PARTICULAR LOT NUMBER. CATHETERS ARE SAID THE BE HARD TO FLUSH, VERY STIFF AND IF THE CATHETER HAS ANY TYPE OF KINK IT WOULD QUIT WORKING." A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NO PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729659 ↗
• InjurySep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER INSERTING THE LINE, WHILE PULLING IT OUT THE NEEDLE DETACHED FROM THE LINE AND CAME APART INSIDE OF A PATIENT. ADDITIONAL INFO RECEIVED ON 05-SEP-2023. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. PATIENT WAS SENT TO OR URGENTLY TO HAVE CATHETER REMOVED. THERE WAS NOT AN INTERRUPTION OR CLINICALLY SIGNIFICANT DELAY IN MEDICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17729489 ↗
• MalfunctionSep 12, 2023Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED THAT AFTER INSERTING THE LINE, WHILE PULLING IT OUT THE NEEDLE DETACHED FROM THE LINE AND CAME APART INSIDE OF A PATIENT. WIRE HAD TO BE REMOVED BY IN THE OR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17729305 ↗
• InjuryJul 12, 2023Break; Break

  IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTED TO PLACE MIDLINE TO LEFT CEPHALIC VESSEL. VESSEL ACCESSED WITHOUT DIFFICULTY USING 20G/8CM POWERGLIDE PRO MIDLINE, GUIDEWIRE THREADED WITHOUT DIFFICULTY BUT CATHETER MET RESISTANCE W / THREADING. WHEN MIDLINE DEVICE PULLED, NOTED CATHETER NON-INTACT AND GUIDEWIRE BENT. NON-DIAGNOSTIC ULTRASOUND OF LUE NOTED NO CATHETER SEEN IN LT CEPHALIC VESSEL, SHADOW NOTED IN SUBCUTANEOUS TISSUES NEAR LT CEPHALIC VESSEL. ADDITIONAL INFO FROM CUSTOMER: (26/6/2023). PATIENT HAS HISTORY OF MULTIPLE CO-MORBIDITIES TO INCLUDE SEPSIS, ATRIAL FIB, ENCEPHALOPATHY/DEMENTIA, ANEMIA, RESPIRATORY FAILURE, MALNUTRITION, ASPIRATION PNEUMONIA. A SAME DAY SURGERY WAS REQUIRED, SURGICAL INTERVENTION TO REMOVE THE SHEARED PIECE OF CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17313094 ↗
• InjuryJun 22, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE GUIDE WIRE MAY HAVE SHEARED OFF. ADDITIONAL INFORMATION RECEIVED 6/13/2023: CUSTOMER REPORTED THAT THE GUIDE WIRE SHEARED OFF DURING INSERTION AND PATIENT REQUIRED A 90 MINUTE SITE TO REMOVE. CLINICIAN THINKS THIS IS IMPART DUE TO THE DIFFICULTY GETTING OFF THE CATHETER. CUSTOMER STATES THAT IF THIS HAS OCCURRED IN THE VEIN - THE PATIENT COULD HAVE POTENTIALLY VERY SERIOUS EVENT. ADDITIONAL INFORMATION GATHERED FROM MD (END-USER) TODAY: ATTEMPTED TO CANNULATE THE BRACHIAL VEIN, THE WIRE WAS DEPLOYED OUTSIDE THE VEIN, JUST BESIDE THE BRACHIAL VEIN, INTO THE INTERSTITIAL TISSUE. THEY NOTICE OVER THE PAST 6 MONTHS, IT IS DIFFICULT TO DEPLOY THE GUIDEWIRE, EVEN OUT OF THE PACKAGE WHEN TESTING IT PRIOR TO INSERTION, IT FEELS LIKE A ¿JOLT OR ABRUPT DEPLOYMENT.¿ THE OTHER MD WAS THE ONE WHO INSERTED THE POWERGLIDEPRO, SHE SAID IT DIDN'T FEEL RIGHT SO SHE PULLED IT OUT AFTER THE WIRE WAS DEPLOYED. WHEN SHE PULLED IT OUT, THE GUIDEWIRE REMAIN IN THE ARM, PATIENT WENT TO THE OR TO HAVE IT REMOVED. SHE STATED, IT FEELS LIKE THEY REALLY HAVE TO ¿REEF¿ ON THE DEVICE TO HAVE IT DEPLOY AND WHEN IT ACTUALLY DOES, IT GOES VERY FAST, PERHAPS CAUSING THE NEEDLE TO POP OUT OF

  Patient problems: Foreign Body In Patient

  MAUDE report 17184331 ↗
• InjuryJun 2, 2023Break; Break

  IT WAS REPORTED VIA MEDWATCH ¿THIS RN WAS ASKED TO RE-VISIT A POSSIBLE PICC LINE FOR CONTINUED ELECTROLYTE SUPPLEMENTATION AND FREQUENT LAB DRAWS. PATIENT DECLINED "I HAVE A HEART ISSUE, I DON'T LIKE THE IDEA OF THAT". PATIENT EDUCATED THAT PICC LINE DOES NOT GO INTO THE HEART BUT DECLINED. DISCUSSED THE OPTION OF A MIDLINE. EXPLAINED THAT IT IS 8CM AND WOULD NOT GO PAST SHOULDER. PATIENT AGREED. ARM PREPPED WITH A MINUTE. CHG SCRUB, AND POWER MIDLINE ATTEMPTED. ULTRASOUND USED. BLOOD RETURN NOTED AND ADVANCEMENT. GUIDEWIRE WITHOUT DIFFICULTY. RESISTANCE MET WHILE ADVANCING CATHETER. ADVANCEMENT STOPPED. IMMEDIATELY AND REMOVAL OF ENTIRE POWERGLIDE SYSTEM. CATHETER NOTED TO NOT BE INTACT. APPROXIMATELY. HALF OF THE CATHETER NOTED IN THE POWERGLIDE SYSTEM. TORNIQUET APPLIED AND DIRECT PRESSURE. PHLEBOTOMIST IN ROOM AND ASSISTED WITH PRESSURE. PROVIDERS NOTIFIED. PATIENT WITHOUT SHORTNESS OF BREATH. NO COMPLAINTS.¿ ADDITIONAL INFORMATION RECEIVED ON 31-MAY-2023: CUSTOMER REPORTED THE FOLLOWING: PATIENT CARE WAS DELAYED DUE TO PATIENT REFUSING A CENTRAL LINE AND HIS OTHER ARM WAS NOT AN OPTION FOR ACCESS. THE EVENT CREATED AN URGENT MEDICAL SITUATION TO REMOVE THE CATHETER SEGMENT TO

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 17053244 ↗
• InjuryMay 15, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER, THE POWERGLIDE CATHETER BROKE IN IN HALF UPON REMOVING AFTER HITTING OBSTRUCTION. ADDITIONAL INFORMATION 05/09/2023: PATIENT NEEDED TO HAVE ADDITIONAL SURGERY TO REMOVE RETAINED CATHETER. THEY WERE BEING TREATED FOR C-DIFF AND CRYPTOSPORIDIUM, ELECTROLYTE IMBALANCE. THEY DO HAVE AN INFECTION DISEASE.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 16935912 ↗