EOPARecalls & reported problems across all models
Medtronic, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one EOPA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 129
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls
- 6
We found 28 models of EOPA by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Jan 24, 2020 and Sep 30, 2026 — classified as 1 death, 5 injuries, 123 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (43 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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
Reports received per month, all models
EOPA 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 24, 2026Open, Classified
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2809-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 24, 2026Open, Classified
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2808-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 24, 2026Open, Classified
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2807-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 24, 2026Open, Classified
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2806-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 12, 2024Open, Classified
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Z-0985-2025 · Root cause: Packaging · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1793-2024 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
Most reported EOPA problems
Device problems
- Material Deformation43
- Fluid/Blood Leak27
- Mechanical Problem25
- Material Puncture/Hole19
- Material Separation12
- Crack8
- Break7
- Contamination7
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- Hemorrhage/Blood Loss/Bleeding15
- No Consequences Or Impact To Patient3
- Exsanguination1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
EOPA models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EOPA™ 77422Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- EOPA™ 77622Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- EOPA™ 77420Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall14 reports
- EOPA™ 77522Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall10 reports
- EOPA™ 77524Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall5 reports
- EOPA™ 77418Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall5 reports
- EOPA™ 77522Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall1 report
- EOPA™ 77722Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- EOPA™ 77424Catheter, cannula and tubing, vascular, cardiopulmonary bypass17 reports
- EOPA™ 77620Catheter, cannula and tubing, vascular, cardiopulmonary bypass10 reports
- EOPA™ 77422Catheter, cannula and tubing, vascular, cardiopulmonary bypass8 reports
- EOPA™ 77624Catheter, cannula and tubing, vascular, cardiopulmonary bypass7 reports
- EOPA™ 77520Catheter, cannula and tubing, vascular, cardiopulmonary bypass4 reports
- EOPA™ 77420Catheter, cannula and tubing, vascular, cardiopulmonary bypass4 reports
- EOPA™ 77620Catheter, cannula and tubing, vascular, cardiopulmonary bypass4 reports
- EOPA™ 77718Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- EOPA™ 77520Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- EOPA™ 77618Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 death2 reports
- EOPA™ CB77420Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- EOPA™ CB77522Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- EOPA™ 77522CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- EOPA™ 77722CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- EOPA™ 77418CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- EOPA™ 77420CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- EOPA™ 77622CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- EOPA™ 77518Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- EOPA™ 77724Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
- EOPA™ 77622Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 report
Recent EOPA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Deformation; Packaging Problem
It was reported that prior to the operation, an EOPA arterial cannula was identified upon opening the package with a squashed and flattened tip. The packaging heat-seal area was damaged and showed blue ink and lines corresponding to the cannula wire-wound tip section. It was alleged that the cannula tip was positioned in the packaging heat-seal area during manufacturing and was crushed by heat-sealing equipment. The cannula was unusable and was replaced with another EOPA cannula without delay to the operation. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942847 ↗MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940762 ↗InjurySep 29, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50934037 ↗MalfunctionSep 25, 2026Material Puncture/Hole
It was reported that during use of the EOPA Arterial cannula, a small pinhole was found in the body of the cannula. The damage was not located at the sutures. The hemostasis cap was used when the introducer was inserted into the cannula body connector. The cannula was replaced to complete the case. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898237 ↗MalfunctionSep 24, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885622 ↗MalfunctionSep 21, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848653 ↗MalfunctionSep 16, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791870 ↗MalfunctionSep 16, 2026Delivered as Unsterile Product
Medtronic received information that prior to use of a EOPA Arterial Cannula, it was reported that the packaging seal was noted to be crimped on the dilator tubing and the peel pouch was not sealed. The customer mentioned that the package looks like when it was sealed, it may have stamped on the hard plastic straw, imprinting the seal pattern. See attached photos. The device was replaced. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790550 ↗InjurySep 15, 2026Fluid/Blood Leak; Material Puncture/Hole
Medtronic received information that during use of a EOPA Arterial cannula, a small hole was identified in the wirewound section of the cannula, with an alleged leak. Blood was observed dripping from the operating table, and the hole was initially not visible because it was partially obscured by surgical drapes. Approximately 300 mL of blood loss was reported. The hole was patched with bone wax, and the operation was completed using the cannula. No blood transfusion was required. The patient was alive with no injury, and no patient harm was reported. Medtronic received additional information that the Leak was from the cannula, in the wirewound section, not near a connector. The cannula was not heated or cooled prior to use, and the damage was not in the location of the sutures.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50770209 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Medtronic received information that during use of a EOPA Arterial Cannula, a pinhole leak was observed in the cannula body. No patient blood loss occurred, and no unplanned blood transfusion was required. The cannula was replaced to complete the case. There was no adverse patient effect associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769157 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Medtronic received information that during use of a EOPA Arterial Cannula, a pinhole leak was observed in the cannula body. No patient blood loss occurred, and no unplanned blood transfusion was required. The cannula was replaced to complete the case. There was no adverse patient effect associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50768521 ↗MalfunctionSep 14, 2026Material Deformation
Medtronic received information that prior to use of a 18FR EOPA Arterial Cannula, it was reported that the device was damaged and kinked. The device was replaced. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757015 ↗MalfunctionSep 9, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691920 ↗MalfunctionSep 9, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691615 ↗MalfunctionAug 19, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50321462 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
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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