Precision Delivery IV Extension Set PDT05CV2Recalls & reported problems
Quest Medical Inc · Class 2
All models of Precision Delivery IV Extension Set (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00634624921412), received between Oct 20, 2022 and Dec 16, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 23, 2022Class IIOpen, Classified
Delivery Sets may have tubing that could become detached that could result in patient infection.
Z-1100-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Loss of or Failure to Bond5
- Fluid/Blood Leak4
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2022Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak
IT WAS REPORTED IN MEDWATCH (B)(4) OF AN ALLEGED INCIDENT INVOLVING QUEST PRECISION DELIVERY SETS. IN THE REPORT, IT STATED THAT THESE SETS WERE ALLEGEDLY LEAKING AND BREAKING DURING ONGOING IV INFUSIONS, RESULTING IN NEW LINES NEEDING TO BE SET UP AND REPLACED DURING VARIOUS INFUSIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000470 ↗MalfunctionDec 16, 2022Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak
IT WAS REPORTED IN MEDWATCH (B)(4) OF AN ALLEGED INCIDENT INVOLVING QUEST PRECISION DELIVERY SETS. IN THE REPORT, IT STATED THAT THESE SETS WERE ALLEGEDLY LEAKING AND BREAKING DURING ONGOING IV INFUSIONS, RESULTING IN NEW LINES NEEDING TO BE SET UP AND REPLACED DURING VARIOUS INFUSIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000468 ↗MalfunctionDec 16, 2022Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak
IT WAS REPORTED IN MEDWATCH (B)(4) OF AN ALLEGED INCIDENT INVOLVING QUEST PRECISION DELIVERY SETS. IN THE REPORT, IT STATED THAT THESE SETS WERE ALLEGEDLY LEAKING AND BREAKING DURING ONGOING IV INFUSIONS, RESULTING IN NEW LINES NEEDING TO BE SET UP AND REPLACED DURING VARIOUS INFUSIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000390 ↗MalfunctionDec 16, 2022Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak
IT WAS REPORTED IN MEDWATCH (B)(4) OF AN ALLEGED INCIDENT INVOLVING QUEST PRECISION DELIVERY SETS. IN THE REPORT, IT STATED THAT THESE SETS WERE ALLEGEDLY LEAKING AND BREAKING DURING ONGOING IV INFUSIONS, RESULTING IN NEW LINES NEEDING TO BE SET UP AND REPLACED DURING VARIOUS INFUSIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000371 ↗MalfunctionOct 20, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) OF AN ALLEGED ISSUE WITH PRECISION DELIVERY SET, STATING THAT THE TUBING WAS ALLEGEDLY PULLING APART AT THE BONDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15643036 ↗
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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 · each recall links to the FDA recall notice
- 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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