Expel™ Drainage Catheter with Twist-Loc™ Hub H7493931108250Recalls & reported problems
Boston Scientific Corporation · MPDL Drainage Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729860587), received between Feb 25, 2019 and Jun 8, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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 18, 2026.
Most reported problems
Device problems
- Break5
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2021Break; Break
IT WAS REPORTED THAT THE SUTURE BROKE. AN 8.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS SELECTED FOR USE AND ATTACHED TO THE PATIENT'S RIGHT CHEST. DURING PROCEDURE, THE DRAINAGE CATHETER WAS INSERTED. AFTER POSITIONING, WHEN IT WAS PULLED, IT WAS NOTED THAT THE SUTURE BROKE. THE DEVICE WAS REMOVED TOGETHER WITH THE SUTURE AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11957717 ↗MalfunctionJan 8, 2021Break; Break
IT WAS REPORTED THAT THE SUTURE BROKE. A 8.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS SELECTED FOR USE AND ATTACHED TO THE PATIENT'S RIGHT CHEST. DURING PROCEDURE, THE DOCTOR TRIED TO INSERT THE FIRST CATHETER AND FELT LOTS OF RESISTANCE. UPON CHECKING THE EXPEL TIP, IT WAS NOTICED THAT IT WAS DEFORMED AND NOT PERFECTLY STRAIGHT EVEN WITH THE STIFFENER INSIDE. WHEN USING THE SECOND CATHETER, IT WAS NOTED THAT THE SUTURE BROKE. BOTH DEVICES WERE MANUALLY REMOVED THE SAME WAY IT WAS INSERTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11141623 ↗MalfunctionApr 21, 2020Break; Break
IT WAS REPORTED THAT THE SUTURE BROKE. AN 8.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE SUTURE BROKE WHEN PULLED TO DEPLOY THE PIG TAIL AFTER INSERTING. THE DEVICE WAS THEN REMOVED AND THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. A NEW EXPEL WAS INSERTED AND COMPLETED THE PROCEDURE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9981676 ↗MalfunctionJun 20, 2019Break; Break
IT WAS REPORTED THAT THE CATHETER BROKE DOWN. AN 8.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS IN A PATIENT FOR ABOUT THREE WEEKS. IT WAS THEN NOTED THAT THE DEVICE LOOKED LIKE IT BROKE DOWN AND ROTTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8716311 ↗MalfunctionMay 15, 2019Break; Break
IT WAS REPORTED THAT SUTURE WAS BROKEN ON THE DEVICE. A 8.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING PREPARATION, THE SUTURE FIXING THE CATHETER TIP WAS DISCONNECTED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8612453 ↗MalfunctionFeb 25, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER HUB WAS DISLODGE. AN 8.3/25 EXPEL DRAINAGE CATHETER WAS SELECTED FOR USE. IT WAS INSERTED FOR A DAY AND FOUND TO BE NOT WORKING WELL. CHEST DRAINAGE WAS PERFORMED; HOWEVER, IT WAS NOTED THAT THE HUB WAS DISLODGED AND THE PHYSICIAN HAD TO CHANGE IT THE NEXT DAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ABLE TO RECOVER AND THE CATHETER CHANGE WAS DONE ON THE SAME DAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8367076 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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