3M™ Micropore™ 1532-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046719352586), received between Dec 3, 2018 and Feb 18, 2019 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE FROM AN OUTPATIENT DIALYSIS CLINIC REPORTED A PATIENT EXPERIENCED A VENOUS DIALYSIS NEEDLE DISLODGEMENT. THE VENOUS NEEDLE WAS ALLEGEDLY SECURED TO THE PATIENT WITH 3M¿ MICROPORE¿ PLUS PAPER TAPE AND 3M¿ TRANSPORE¿ SURGICAL TAPE. THE NURSE REPORTED THE PATIENT FELL ASLEEP DURING DIALYSIS. WHEN THE PATIENT PULLED UP HIS BLANKET, THE VENOUS NEEDLE GOT CAUGHT, AND WAS PULLED OUT. THE PATIENT ALERTED THE STAFF WHO RESPONDED IMMEDIATELY. THE DIALYSIS MACHINE WAS TURNED OFF. THE ESTIMATED BLOOD LOSS WAS 500CC. APPROXIMATELY ONE-HALF PINT OF BLOOD WAS RETURNED THROUGH THE ARTERIAL DIALYSIS NEEDLE. AN UNSPECIFIED AMOUNT OF SALINE WAS ALSO ADMINISTERED THROUGH THE ARTERIAL DIALYSIS NEEDLE. THE PATIENT WAS ALERT AND ORIENTATED DURING THE ENTIRE EVENT. DIALYSIS WAS DISCONTINUED, THE PATIENT WAS MONITORED, AND WAS EVENTUALLY DISCHARGED HOME. THE PATIENT RETURNED TO THE DIALYSIS CLINIC FOR HIS REGULARLY SCHEDULED ROUTINE DIALYSIS TREATMENTS.

  Patient problems: Blood Loss

  MAUDE report 8347904 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ARRIVED FOR TREATMENT ALERT AND ORIENTATED. PRE-DIALYSIS VITAL SIGNS OBTAINED: B/P: 187/62; PULSE 72; RESP 18; TEMP: 98.0. AT 19:59, THE PATIENT WAS OBSERVED WITH THE ACCESS UNCOVERED AND NO BLEEDING FROM SITE. AT 20:01, APPROXIMATELY 2.5 HOURS INTO THE SCHEDULED 4 HOUR HEMODIALYSIS TREATMENT, DURING THE Q 30 MINUTE VITAL SIGNS CHECK, THE PATIENT WAS NOTED TO BE SLOW TO RESPOND. VS OBTAINED: B/P 47/26; PULSE 64. PATIENT'S VENOUS NEEDLE WAS DISLODGED WITH TAPE INTACT ON THE WINGS OF THE NEEDLE. LARGE AMOUNTS OF BLOOD WERE NOTED ON BOTH THE CHAIR AND THE FLOOR. ELB 500 ML. THE VENOUS LINE WAS CLAMPED, AND PRESSURE APPLIED TO THE VENOUS CANNULATION SITE. NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL NEEDLE. 911 WAS CALLED. AFTER INFUSION OF APPROXIMATELY 1000 ML NORMAL SALINE, B/P: 126/53; PULSE 64; PATIENT WAS ALERT AND ORIENTED. UPON DISCHARGE FROM THE FACILITY VIA EMS; THE PATIENT WAS ALERT AND ORIENTED WITH B/P 110/50; PULSE 67; RESP 18. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. THE PATIENT RETURNED TO THE FACILITY FOR HEMODIALYSIS ON (B)(6) 2018.

  Patient problems: Blood Loss; Hypovolemia; Low Blood Pressure/ Hypotension

  MAUDE report 8257683 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OUTPATIENT DIALYSIS FACILITY REPORTED THE FOLLOWING INFORMATION VIA A MEDWATCH FORM. THE REPORTER ALLEGED A PATIENT ARRIVED AT TREATMENT; PRE-DIALYSIS VS OBTAINED: B/P 153/77; PULSE 86; RESP 17; TEMP 97.8. APPROXIMATELY 2 HOURS INTO THE SCHEDULED 4-HOUR HEMODIALYSIS TREATMENT VS OBTAINED WERE: B/P 97/52; PULSE 84. THE ULTRAFILTRATION WAS TURNED OFF AND THE PATIENT'S LEGS WERE ELEVATED. THE MACHINE SUBSEQUENTLY ALARMED VENOUS PRESSURE AND THE BLOOD PUMP STOPPED. THE PATIENT WAS LETHARGIC AND SLOW TO RESPOND VERBALLY WITH THE VENOUS NEEDLE DISLODGED WITH THE TAPE INTACT ON THE WINGS OF THE NEEDLE. BLOOD WAS NOTED TO BE FLOWING DOWN THE INSIDE OF THE CHAIR, A PUDDLE OF BLOOD WAS UNDER THE CHAIR. EBL WAS 1 UNIT. APPROXIMATELY 400 ML NORMAL SALINE WAS ADMINISTERED, EMS WAS CALLED. UPON DISCHARGE FROM THE FACILITY VIA EMS, PATIENT WAS ORIENTED WITH B/P 102/64; PULSE 118. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 1-UNIT PRBC WAS INFUSED IN THE ER.

  Patient problems: Blood Loss; Hypovolemia

  MAUDE report 8226188 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OUTPATIENT DIALYSIS FACILITY REPORTED THE FOLLOWING INFORMATION VIA A MEDWATCH FORM. APPROXIMATELY 2.5 HOURS INTO A SCHEDULED 4-HOUR HEMODIALYSIS TREATMENT, THE DIALYSIS MACHINE ALARMED. UPON ARRIVAL TO THE CHAIRSIDE, THE PATIENT WAS FOUND IN THE HEMODIALYSIS CHAIR WITH HER EYES CLOSED. THE VENOUS FISTULA NEEDLE WAS NOTED TO BE DISLODGED WITH THE TAPE INTACT; BLOOD WAS PUMPING OUT OF THE VENOUS NEEDLE; A POOL OF BLOOD WAS NOTED UNDER THE CHAIR APPROXIMATELY THE SIZE OF THE CHAIR. THE FISTULA LINES WERE STILL TAPED TO THE PATIENT'S ARM. THE BLOOD PUMP WAS STOPPED IMMEDIATELY, AND NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL FISTULA NEEDLE. 911 WAS CALLED. AFTER APPROXIMATELY 400 ML NORMAL SALINE BOLUS, THE PATIENT OPENED HER EYES TO VERBAL INSTRUCTION. A TOTAL OF 1.4 ML NORMAL SALINE WAS ADMINISTERED. THE PATIENT WAS DISCHARGED VIA EMS WITH A B/P OF 129/61. UPON ADMISSION TO THE EMERGENCY ROOM, HER SYSTOLIC BLOOD PRESSURE WAS IN THE 70'S AND SHE WAS BRADYCARDIC. 1 LITER OF FLUID AND 2 UNITS PRBC WERE INFUSED. SHE WAS ADMITTED TO THE ICU FOR HEMORRHAGIC SHOCK AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018, RETURNING FOR HER NEXT SCHEDULED IN CENTER HEMODIALYSIS TREATMENT ON (B

  Patient problems: Blood Loss; Hypovolemia; Loss of consciousness

  MAUDE report 8123797 ↗