Precision Delivery IV Extension SetRecalls & reported problems across all models
Quest Medical Inc · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Precision Delivery IV Extension Set model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 3 models of Precision Delivery IV Extension Set by Quest Medical Inc in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2022 and Dec 16, 2022 — classified as 3 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Precision Delivery IV Extension Set recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 23, 2022Open, Classified
Delivery Sets may have tubing that could become detached that could result in patient infection.
Z-1100-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Precision Delivery IV Extension Set problems
Device problems
- Loss of or Failure to Bond12
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Unspecified Infection3
Precision Delivery IV Extension Set models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Precision Delivery IV Extension Set PDT05CV2Set, Administration, Intravascular1 recall5 reports
- Precision Delivery IV Extension Set PD06FSet, Administration, Intravascular1 recall4 reports
- Precision Delivery IV Extension Set PDB05CV1Set, Administration, Intravascular3 reports
Recent Precision Delivery IV Extension Set adverse event reports
The 12 most recent reports across all models, 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 2233020000-2022-8010 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 16000430 ↗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 ↗InjuryOct 29, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) HOSPITAL OF (B)(6) OF AN ALLEGED ISSUE WITH PRECISION DELIVERY SETS. THE REPORT STATED THAT THE SET BONDING WAS ALLEGEDLY NOT HOLDING AND THAT THERE WAS AN INSTANCE OF BLOOD STREAM INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15696430 ↗InjuryOct 29, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED TO QUEST MEDICAL BY CHILDREN'S HOSPITAL OF BOSTON OF AN ALLEGED ISSUE WITH PRECISION DELIVERY SETS. THE REPORT STATED THAT THE SET BONDING WAS ALLEGEDLY NOT HOLDING AND THAT THERE WAS AN INSTANCE OF BLOOD STREAM INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15696038 ↗InjuryOct 29, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED TO QUEST MEDICAL BY CHILDREN'S HOSPITAL OF BOSTON OF AN ALLEGED ISSUE WITH PRECISION DELIVERY SETS. THE REPORT STATED THAT THE SET BONDING WAS ALLEGEDLY NOT HODLING AND THAT THERE WAS AN INSTANCE OF BLOOD STREAM INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15695554 ↗MalfunctionOct 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED TO QUEST MEDICAL BY CHILDREN'S HOSPITAL OF BOSTON OF AN ALLEGED ISSUE WITH PRECISION DELIVERY SETS, STATING THAT THE TUBING WAS ALLEGEDLY PULLING APART AT THE BONDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677800 ↗MalfunctionOct 26, 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 15677799 ↗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 15643065 ↗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 ↗
Other Quest Medical Inc products
All Quest Medical Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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