Port Access NeedleRecalls & reported problems across all models
Bard Access Systems, Inc. · 122 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,744
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls
- 3
We found 122 models of Port Access Needle by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 3,744 adverse event reports in the FDA's MAUDE database, received between Jun 16, 2017 and Sep 30, 2026 — classified as 76 injuries, 3,668 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1,925 reports).
3 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
Port Access Needle 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.
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2671-2020 · Root cause: Process control · names 12 of these models · Recall details · FDA record ↗
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2670-2020 · Root cause: Process control · names 18 of these models · Recall details · FDA record ↗
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2669-2020 · Root cause: Process control · names 11 of these models · Recall details · FDA record ↗
Most reported Port Access Needle problems
Device problems
- Fluid/Blood Leak1,925
- Activation Problem476
- Crack316
- Material Deformation203
- Break193
- Leak/Splash171
- Material Twisted/Bent153
- Detachment of Device or Device Component122
Patient problems
- No Clinical Signs, Symptoms or Conditions2,159
- No Consequences Or Impact To Patient597
- No Known Impact Or Consequence To Patient404
- No Patient Involvement200
- Chemical Exposure107
- Insufficient Information85
- Needle Stick/Puncture81
- Pain54
Port Access Needle models
122 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Port Access Needle LH-0029Set, administration, intravascular1 recall379 reports
- Port Access Needle 8652034Set, administration, intravascular402 reports
- Port Access Needle LH-0031Set, administration, intravascular1 recall350 reports
- Port Access Needle 0142075Set, administration, intravascular1 recall307 reports
- Port Access Needle LH-0031YNSet, administration, intravascular1 recall287 reports
- Port Access Needle 0132075Set, administration, intravascular1 recall260 reports
- Port Access Needle LH-0029YNSet, administration, intravascular1 recall177 reports
- Port Access Needle LH-0033YNSet, administration, intravascular1 recall96 reports
- Port Access Needle LH-0035Set, administration, intravascular1 recall71 reports
- Port Access Needle LH-0032YNSet, administration, intravascular1 recall53 reports
- Port Access Needle LH-0033Set, administration, intravascular1 recall49 reports
- Port Access Needle 0131975Set, administration, intravascular1 recall38 reports
- Port Access Needle 0132010Set, administration, intravascular1 recall37 reports
- Port Access Needle 0142010Set, administration, intravascular1 recall37 reports
- Port Access Needle 0632034Set, administration, intravascular87 reports
- Port Access Needle LH-0032Set, administration, intravascular1 recall33 reports
- Port Access Needle 012034NYSet, administration, intravascular77 reports
- Port Access Needle 0142275Set, administration, intravascular1 recall25 reports
- Port Access Needle LH-0037Set, administration, intravascular1 recall24 reports
- Port Access Needle 0141975Set, administration, intravascular1 recall22 reports
- Port Access Needle 0131910Set, administration, intravascular1 recall17 reports
- Port Access Needle 0652034Set, administration, intravascular67 reports
- Port Access Needle 0672034Set, administration, intravascular66 reports
- Port Access Needle 012001NYSet, administration, intravascular64 reports
- Port Access Needle LH-0035YNSet, administration, intravascular1 recall14 reports
- Port Access Needle LH-0030Set, administration, intravascular1 recall13 reports
- Port Access Needle 0132275Set, administration, intravascular1 recall10 reports
- Port Access Needle LH-0034YNSet, administration, intravascular1 recall9 reports
- Port Access Needle LH-0030YNSet, administration, intravascular1 recall8 reports
- Port Access Needle SHG19-75Set, administration, intravascular58 reports
- Port Access Needle LH-0034Set, administration, intravascular1 recall6 reports
- Port Access Needle LH-0039Set, administration, intravascular1 recall5 reports
- Port Access Needle 0141910Set, administration, intravascular1 recall4 reports
- Port Access Needle 0142015Set, administration, intravascular1 recall4 reports
- Port Access Needle 0142210Set, administration, intravascular1 recall4 reports
- Port Access Needle LH-0038Set, administration, intravascular1 recall4 reports
- Port Access Needle 0141915Set, administration, intravascular1 recall2 reports
- Port Access Needle LH-0037YNSet, administration, intravascular1 recall2 reports
- Port Access Needle 0131915Set, administration, intravascular1 recall1 report
- Port Access Needle 0132210Set, administration, intravascular1 recall1 report
- Port Access Needle LH-0038YNSet, administration, intravascular1 recall1 report
- Port Access Needle 0132015Set, administration, intravascular1 recall0 reports
- Port Access Needle 0132215Set, administration, intravascular1 recall0 reports
- Port Access Needle 0142215Set, administration, intravascular1 recall0 reports
- Port Access Needle LH-0036Set, administration, intravascular1 recall0 reports
- Port Access Needle LH-0036YNSet, administration, intravascular1 recall0 reports
- Port Access Needle LH-0040Set, administration, intravascular1 recall0 reports
- Port Access Needle LH-0040YNSet, administration, intravascular1 recall0 reports
- Port Access Needle S02320-75Set, administration, intravascular38 reports
- Port Access Needle 8672034Set, administration, intravascular34 reports
- Port Access Needle 0632010Set, administration, intravascular33 reports
- Port Access Needle 0682034Set, administration, intravascular31 reports
- Port Access Needle 0672010Set, administration, intravascular29 reports
- Port Access Needle 2205220Needle, hypodermic, single lumen27 reports
- Port Access Needle S02020-10Set, administration, intravascular22 reports
- Port Access Needle 0632234Set, administration, intravascular21 reports
- Port Access Needle S02020-75Set, administration, intravascular18 reports
- Port Access Needle 0671910Set, administration, intravascular17 reports
- Port Access Needle 0604190Needle, hypodermic, single lumen17 reports
- Port Access Needle 2206220Needle, hypodermic, single lumen17 reports
- Port Access Needle 012034Set, administration, intravascular16 reports
- Port Access Needle SHW20-75YSSet, administration, intravascular16 reports
- Port Access Needle 0671934Set, administration, intravascular15 reports
- Port Access Needle 0681934Set, administration, intravascular15 reports
- Port Access Needle 2205222Needle, hypodermic, single lumen15 reports
- Port Access Needle 0652010Set, administration, intravascular14 reports
- Port Access Needle 012234Set, administration, intravascular14 reports
- Port Access Needle 0682010Set, administration, intravascular13 reports
- Port Access Needle 0604200Needle, hypodermic, single lumen13 reports
- Port Access Needle 585112Set, administration, intravascular10 reports
- Port Access Needle 0604180Needle, hypodermic, single lumen9 reports
- Port Access Needle 012001Set, administration, intravascular7 reports
- Port Access Needle 0652234Set, administration, intravascular6 reports
- Port Access Needle SHG20-100Set, administration, intravascular6 reports
- Port Access Needle SHN20-60Set, administration, intravascular6 reports
- Port Access Needle 0631934Set, administration, intravascular5 reports
- Port Access Needle SHG20-75Set, administration, intravascular5 reports
- Port Access Needle 583112Set, administration, intravascular4 reports
- Port Access Needle 0651934Set, administration, intravascular4 reports
- Port Access Needle 0682234Set, administration, intravascular4 reports
- Port Access Needle 2206219Needle, hypodermic, single lumen4 reports
- Port Access Needle SHG22-100YSet, administration, intravascular4 reports
- Port Access Needle SHW20-75YSet, administration, intravascular4 reports
- Port Access Needle 0632015Set, administration, intravascular3 reports
- Port Access Needle S02022-75Set, administration, intravascular3 reports
- Port Access Needle 2206222Needle, hypodermic, single lumen3 reports
- Port Access Needle 0631910Set, administration, intravascular2 reports
- Port Access Needle 0632210Set, administration, intravascular2 reports
- Port Access Needle 0652015Set, administration, intravascular2 reports
- Port Access Needle 0672234Set, administration, intravascular2 reports
- Port Access Needle 0681910Set, administration, intravascular2 reports
- Port Access Needle S02019-75Set, administration, intravascular2 reports
- Port Access Needle S02320-10Set, administration, intravascular2 reports
- Port Access Needle S02322-75Set, administration, intravascular2 reports
- Port Access Needle 011901NYSet, administration, intravascular2 reports
- Port Access Needle 012005Set, administration, intravascular2 reports
- Port Access Needle 0604220Needle, hypodermic, single lumen2 reports
- Port Access Needle SHG19-100Set, administration, intravascular2 reports
- Port Access Needle SHG22-75Set, administration, intravascular2 reports
- Port Access Needle SHG22-75YSet, administration, intravascular2 reports
Recent Port Access Needle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954904 ↗MalfunctionSep 30, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954899 ↗MalfunctionSep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953976 ↗MalfunctionSep 24, 2026Failure to Infuse
It was reported that health professional performed the puncture but encountered resistance during the injection of the solution. health professional replaced the SurePlug, but the problem persisted. This appears to be a needle malfunction. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883626 ↗MalfunctionSep 23, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873055 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873044 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported the patient was receiving infusion therapy using an implanted port access needle on (b)(6). The catheter was flushed and locked daily according to standard procedures. On August 4, leakage was observed at the infusion connector during administration. The connector was replaced; however, leakage persisted. Further observation determined that the issue was not with the connector itself, but rather a crack at the needle hub/connector area. As a result, infusion could not be continued, and the implanted port access needle was removed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870559 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported a chest wall infusion cannula was implanted in the patient. After changing the dressing, an indwelling cannula for the implantable drug delivery system was inserted. Backflow was observed upon suction, the cannula was flushed and found to be unobstructed, and the fluid began to drip smoothly. The system functioned normally for four consecutive days. On the fifth day, while administering the infusion, the nurse noticed a crack in the tubing connected to the infusion cannula. Flushing revealed a leak, rendering the system inoperable. The infusion cannula was removed, and a new drug delivery system was inserted via a new puncture site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870556 ↗MalfunctionSep 23, 2026Activation Problem
It was reported we had a needlestick with a reproducible faulty safety in the product. No further information was provided.
Patient problems: Needle Stick/Puncture
MAUDE report 50863225 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863112 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862359 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861491 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858512 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858510 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that on (b)(6) 2026, in accordance with the physician¿s orders, a single-use implantable drug delivery device with an indwelling cannula was used to administer an IV infusion to the patient. During use, it was discovered that the cannula hub had fractured and become loose. Use was immediately discontinued, and a new drug delivery device was used to treat the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846049 ↗
Other Bard Access Systems, Inc. products
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
- Navarre Opti-Drain8 models · 1,197 reports
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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